CHEST Physician

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Key clinical point: Development of bacteremia in immunocompetent adult patients managed in the ICU for severe pneumococcal community-acquired pneumonia (CAP) had no effect on mortality.

Main finding: In-hospital mortality (21.5% vs. 16.9%; P = .11) or baseline variables associated with in-hospital death, such as the age ≥65 years (P interaction = .45) and bilateral pulmonary infection (P interaction = .77), were not significantly different between patients with and without bacteremia.

Study details: This was a post hoc analysis of the prospective STREPTOGENE study including 614 immunocompetent adult white patients admitted to an ICU for severe pneumococcal CAP. Of these, 270 patients had a positive blood culture for Streptococcus pneumoniae at admission.

Disclosures: The study was sponsored by 2 public health care and research agencies: the Assistance Publique Hôpitaux de Paris and Délégation à la Recherche Clinique et au Développement. None of the authors declared any conflict of interests.

Source: Bellut H et al. Ann Intensive Care. 2021;11:148 (Oct 24). Doi: 10.1186/s13613-021-00936-z.

Key clinical point: Development of bacteremia in immunocompetent adult patients managed in the ICU for severe pneumococcal community-acquired pneumonia (CAP) had no effect on mortality.

Main finding: In-hospital mortality (21.5% vs. 16.9%; P = .11) or baseline variables associated with in-hospital death, such as the age ≥65 years (P interaction = .45) and bilateral pulmonary infection (P interaction = .77), were not significantly different between patients with and without bacteremia.

Study details: This was a post hoc analysis of the prospective STREPTOGENE study including 614 immunocompetent adult white patients admitted to an ICU for severe pneumococcal CAP. Of these, 270 patients had a positive blood culture for Streptococcus pneumoniae at admission.

Disclosures: The study was sponsored by 2 public health care and research agencies: the Assistance Publique Hôpitaux de Paris and Délégation à la Recherche Clinique et au Développement. None of the authors declared any conflict of interests.

Source: Bellut H et al. Ann Intensive Care. 2021;11:148 (Oct 24). Doi: 10.1186/s13613-021-00936-z.

Key clinical point: Development of bacteremia in immunocompetent adult patients managed in the ICU for severe pneumococcal community-acquired pneumonia (CAP) had no effect on mortality.

Main finding: In-hospital mortality (21.5% vs. 16.9%; P = .11) or baseline variables associated with in-hospital death, such as the age ≥65 years (P interaction = .45) and bilateral pulmonary infection (P interaction = .77), were not significantly different between patients with and without bacteremia.

Study details: This was a post hoc analysis of the prospective STREPTOGENE study including 614 immunocompetent adult white patients admitted to an ICU for severe pneumococcal CAP. Of these, 270 patients had a positive blood culture for Streptococcus pneumoniae at admission.

Disclosures: The study was sponsored by 2 public health care and research agencies: the Assistance Publique Hôpitaux de Paris and Délégation à la Recherche Clinique et au Développement. None of the authors declared any conflict of interests.

Source: Bellut H et al. Ann Intensive Care. 2021;11:148 (Oct 24). Doi: 10.1186/s13613-021-00936-z.

Key clinical point: Pneumococcal urinary antigen testing (PUAT) effectuated early de-escalation of broad-spectrum antibiotics among positive patients with community-acquired pneumonia (CAP) and thus should be widely performed to substantiate antimicrobial stewardship interventions.

Main finding: PUAT-positive patients showed a significantly shorter median (interquartile range) time to de-escalation vs. PUAT-negative patients (1 [0-2] days vs. 1 [1-2] days; P = .01) and a higher atypical (azithromycin or doxycycline) coverage discontinuation rate within 24 hours of PUAT (61.3% vs. 47.2%; P = .026), with no significant difference in methicillin-resistant Staphylococcus aureus agent discontinuation (P = .610) or antipseudomonal de-escalation (P = .895).

Study details: The data come from a retrospective chart review study including 910 adult patients who were hospitalized for CAP and, as part of the diagnostic procedure, underwent PUAT, which returned a positive result in 121 patients.

Disclosures: The authors reported no financial support or conflict of interests.

Source: Greenfield A et al. Open Forum Infect Dis. 2021;ofab522 (Oct 22). Doi: 10.1093/ofid/ofab522.

Key clinical point: Pneumococcal urinary antigen testing (PUAT) effectuated early de-escalation of broad-spectrum antibiotics among positive patients with community-acquired pneumonia (CAP) and thus should be widely performed to substantiate antimicrobial stewardship interventions.

Main finding: PUAT-positive patients showed a significantly shorter median (interquartile range) time to de-escalation vs. PUAT-negative patients (1 [0-2] days vs. 1 [1-2] days; P = .01) and a higher atypical (azithromycin or doxycycline) coverage discontinuation rate within 24 hours of PUAT (61.3% vs. 47.2%; P = .026), with no significant difference in methicillin-resistant Staphylococcus aureus agent discontinuation (P = .610) or antipseudomonal de-escalation (P = .895).

Study details: The data come from a retrospective chart review study including 910 adult patients who were hospitalized for CAP and, as part of the diagnostic procedure, underwent PUAT, which returned a positive result in 121 patients.

Disclosures: The authors reported no financial support or conflict of interests.

Source: Greenfield A et al. Open Forum Infect Dis. 2021;ofab522 (Oct 22). Doi: 10.1093/ofid/ofab522.

Key clinical point: Pneumococcal urinary antigen testing (PUAT) effectuated early de-escalation of broad-spectrum antibiotics among positive patients with community-acquired pneumonia (CAP) and thus should be widely performed to substantiate antimicrobial stewardship interventions.

Main finding: PUAT-positive patients showed a significantly shorter median (interquartile range) time to de-escalation vs. PUAT-negative patients (1 [0-2] days vs. 1 [1-2] days; P = .01) and a higher atypical (azithromycin or doxycycline) coverage discontinuation rate within 24 hours of PUAT (61.3% vs. 47.2%; P = .026), with no significant difference in methicillin-resistant Staphylococcus aureus agent discontinuation (P = .610) or antipseudomonal de-escalation (P = .895).

Study details: The data come from a retrospective chart review study including 910 adult patients who were hospitalized for CAP and, as part of the diagnostic procedure, underwent PUAT, which returned a positive result in 121 patients.

Disclosures: The authors reported no financial support or conflict of interests.

Source: Greenfield A et al. Open Forum Infect Dis. 2021;ofab522 (Oct 22). Doi: 10.1093/ofid/ofab522.

Key clinical point: Heparin-binding protein (HBP) may outperform the conventional biomarkers in predicting disease progression in children with severe community-acquired pneumonia (CAP).

Main finding: After adjusting for age, high HBP levels showed an independent correlation with respiratory failure (RF; odds ratio [OR] 1.008; 95% CI 1.003-1.013) in children with severe CAP. Among other biomarkers, HBP exhibited the highest predictive power for identifying children developing RF or sepsis, yielding areas under the receiver operating characteristic curves of 0.68 and 0.85, respectively, along with the best specificity at 96.3%.

Study details: Findings are from a retrospective observational study on 157 children who were admitted to an ICU ward for severe CAP, of which 106 presented with RF and 48 developed sepsis.

Disclosures: The study was sponsored by the Changsha Science and Technology Bureau Science Foundation, China. The authors declared no conflict of interests.

Source: Huang C et al. Front Pediatr. 2021 (Oct 28). Doi: 10.3389/fped.2021.759535.

Key clinical point: Heparin-binding protein (HBP) may outperform the conventional biomarkers in predicting disease progression in children with severe community-acquired pneumonia (CAP).

Main finding: After adjusting for age, high HBP levels showed an independent correlation with respiratory failure (RF; odds ratio [OR] 1.008; 95% CI 1.003-1.013) in children with severe CAP. Among other biomarkers, HBP exhibited the highest predictive power for identifying children developing RF or sepsis, yielding areas under the receiver operating characteristic curves of 0.68 and 0.85, respectively, along with the best specificity at 96.3%.

Study details: Findings are from a retrospective observational study on 157 children who were admitted to an ICU ward for severe CAP, of which 106 presented with RF and 48 developed sepsis.

Disclosures: The study was sponsored by the Changsha Science and Technology Bureau Science Foundation, China. The authors declared no conflict of interests.

Source: Huang C et al. Front Pediatr. 2021 (Oct 28). Doi: 10.3389/fped.2021.759535.

Key clinical point: Heparin-binding protein (HBP) may outperform the conventional biomarkers in predicting disease progression in children with severe community-acquired pneumonia (CAP).

Main finding: After adjusting for age, high HBP levels showed an independent correlation with respiratory failure (RF; odds ratio [OR] 1.008; 95% CI 1.003-1.013) in children with severe CAP. Among other biomarkers, HBP exhibited the highest predictive power for identifying children developing RF or sepsis, yielding areas under the receiver operating characteristic curves of 0.68 and 0.85, respectively, along with the best specificity at 96.3%.

Study details: Findings are from a retrospective observational study on 157 children who were admitted to an ICU ward for severe CAP, of which 106 presented with RF and 48 developed sepsis.

Disclosures: The study was sponsored by the Changsha Science and Technology Bureau Science Foundation, China. The authors declared no conflict of interests.

Source: Huang C et al. Front Pediatr. 2021 (Oct 28). Doi: 10.3389/fped.2021.759535.

Key clinical point: Administration of ceftaroline alone or in combination resulted in lower in-hospital mortality rates in patients with community-acquired pneumonia (CAP) vs. standard therapy.

Main finding: After adjustment for confounding factors, patients receiving ceftaroline had a lower in-hospital mortality rate (13% vs. 21%; adjusted hazard ratio 0.41; P = .031) and longer median hospital stay (13 days vs. 10 days; P = .007) than those receiving standard therapy.

Study details: This retrospective observational study matched 78 patients with CAP who received ceftaroline (as monotherapy or in combination with azithromycin, levofloxacin, etc.) with 78 control patients who received standard therapy.

Disclosures: The study received financial support from Pfizer, CIBER de Enfermedades Respiratorias, and 2009 Support to Research Groups of Catalonia 911, IDIBAPS. Pfizer, in addition to a couple of other sources, provided research grants/fellowships to Dr. Cilloniz and other authors.

Source: Cilloniz C et al. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12). Doi: 10.1007/s10096-021-04378-0.

Key clinical point: Administration of ceftaroline alone or in combination resulted in lower in-hospital mortality rates in patients with community-acquired pneumonia (CAP) vs. standard therapy.

Main finding: After adjustment for confounding factors, patients receiving ceftaroline had a lower in-hospital mortality rate (13% vs. 21%; adjusted hazard ratio 0.41; P = .031) and longer median hospital stay (13 days vs. 10 days; P = .007) than those receiving standard therapy.

Study details: This retrospective observational study matched 78 patients with CAP who received ceftaroline (as monotherapy or in combination with azithromycin, levofloxacin, etc.) with 78 control patients who received standard therapy.

Disclosures: The study received financial support from Pfizer, CIBER de Enfermedades Respiratorias, and 2009 Support to Research Groups of Catalonia 911, IDIBAPS. Pfizer, in addition to a couple of other sources, provided research grants/fellowships to Dr. Cilloniz and other authors.

Source: Cilloniz C et al. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12). Doi: 10.1007/s10096-021-04378-0.

Key clinical point: Administration of ceftaroline alone or in combination resulted in lower in-hospital mortality rates in patients with community-acquired pneumonia (CAP) vs. standard therapy.

Main finding: After adjustment for confounding factors, patients receiving ceftaroline had a lower in-hospital mortality rate (13% vs. 21%; adjusted hazard ratio 0.41; P = .031) and longer median hospital stay (13 days vs. 10 days; P = .007) than those receiving standard therapy.

Study details: This retrospective observational study matched 78 patients with CAP who received ceftaroline (as monotherapy or in combination with azithromycin, levofloxacin, etc.) with 78 control patients who received standard therapy.

Disclosures: The study received financial support from Pfizer, CIBER de Enfermedades Respiratorias, and 2009 Support to Research Groups of Catalonia 911, IDIBAPS. Pfizer, in addition to a couple of other sources, provided research grants/fellowships to Dr. Cilloniz and other authors.

Source: Cilloniz C et al. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12). Doi: 10.1007/s10096-021-04378-0.

Key clinical point: On comparing regimes recommended by the 2019 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, those containing doxycycline were associated with decreased mortality in elderly patients with community-acquired pneumonia (CAP).

Main finding: After propensity-matching, patients receiving beta-lactam + doxycycline showed significantly reduced 30-day (odds ratio [OR] 0.72; 95% CI 0.63-0.84) and 90-day (OR 0.83; 95% CI 0.74-0.92) mortality vs. those on nondoxycycline-containing regimes.

Study details: This retrospective observational cohort study included 70,533 patients aged ≥65 years who were admitted to a non-ICU hospital ward for CAP and received at least 1 dose of the 2019 ATS/IDSA guideline-recommended antimicrobial therapy within 48 hours after admission. Of these, 5,282 patients received doxycycline-containing combinations.

Disclosures: The study was supported by the US National Institute of Nursing Research. CA Alvarez declared serving as an advisory board member for a pharmaceutical organization.

Source: Uddin M et al. Clin Infect Dis. 2021;ciab863 (Nov 9). Doi: 10.1093/cid/ciab863.

Key clinical point: On comparing regimes recommended by the 2019 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, those containing doxycycline were associated with decreased mortality in elderly patients with community-acquired pneumonia (CAP).

Main finding: After propensity-matching, patients receiving beta-lactam + doxycycline showed significantly reduced 30-day (odds ratio [OR] 0.72; 95% CI 0.63-0.84) and 90-day (OR 0.83; 95% CI 0.74-0.92) mortality vs. those on nondoxycycline-containing regimes.

Study details: This retrospective observational cohort study included 70,533 patients aged ≥65 years who were admitted to a non-ICU hospital ward for CAP and received at least 1 dose of the 2019 ATS/IDSA guideline-recommended antimicrobial therapy within 48 hours after admission. Of these, 5,282 patients received doxycycline-containing combinations.

Disclosures: The study was supported by the US National Institute of Nursing Research. CA Alvarez declared serving as an advisory board member for a pharmaceutical organization.

Source: Uddin M et al. Clin Infect Dis. 2021;ciab863 (Nov 9). Doi: 10.1093/cid/ciab863.

Key clinical point: On comparing regimes recommended by the 2019 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, those containing doxycycline were associated with decreased mortality in elderly patients with community-acquired pneumonia (CAP).

Main finding: After propensity-matching, patients receiving beta-lactam + doxycycline showed significantly reduced 30-day (odds ratio [OR] 0.72; 95% CI 0.63-0.84) and 90-day (OR 0.83; 95% CI 0.74-0.92) mortality vs. those on nondoxycycline-containing regimes.

Study details: This retrospective observational cohort study included 70,533 patients aged ≥65 years who were admitted to a non-ICU hospital ward for CAP and received at least 1 dose of the 2019 ATS/IDSA guideline-recommended antimicrobial therapy within 48 hours after admission. Of these, 5,282 patients received doxycycline-containing combinations.

Disclosures: The study was supported by the US National Institute of Nursing Research. CA Alvarez declared serving as an advisory board member for a pharmaceutical organization.

Source: Uddin M et al. Clin Infect Dis. 2021;ciab863 (Nov 9). Doi: 10.1093/cid/ciab863.

Key clinical point: Occurrence of community-acquired pneumonia (CAP) in infants aged below 2 years increases their risk for subsequent respiratory disease when between 2 and 5 years of age.

Main finding: The rate of chronic respiratory disorder from 2-5 years of age, reactive airway disease, and CAP hospitalization after 2 years of age was 2.4-fold (95% CI 2.1-2.6), 3.2-fold (95% CI 2.6-3.8), and 6.3-fold (95% CI 3.6-10.9) higher in patients with CAP vs. comparison patients.

Study details: The data come from a retrospective study including 1,343 infants less than 2 years of age who were hospitalized once or more for CAP and matched with 6,715 comparator infants with no evidence of pneumonia.

Disclosures: The study was sponsored by Pfizer Inc. Some of the authors declared being directly employed by Pfizer or another organization that received financial support from Pfizer.

Source: Lapidot R et al. Repir Med. 2021:106671 (Oct 27). Doi: 10.1016/j.rmed.2021.106671.

Key clinical point: Occurrence of community-acquired pneumonia (CAP) in infants aged below 2 years increases their risk for subsequent respiratory disease when between 2 and 5 years of age.

Main finding: The rate of chronic respiratory disorder from 2-5 years of age, reactive airway disease, and CAP hospitalization after 2 years of age was 2.4-fold (95% CI 2.1-2.6), 3.2-fold (95% CI 2.6-3.8), and 6.3-fold (95% CI 3.6-10.9) higher in patients with CAP vs. comparison patients.

Study details: The data come from a retrospective study including 1,343 infants less than 2 years of age who were hospitalized once or more for CAP and matched with 6,715 comparator infants with no evidence of pneumonia.

Disclosures: The study was sponsored by Pfizer Inc. Some of the authors declared being directly employed by Pfizer or another organization that received financial support from Pfizer.

Source: Lapidot R et al. Repir Med. 2021:106671 (Oct 27). Doi: 10.1016/j.rmed.2021.106671.

Key clinical point: Occurrence of community-acquired pneumonia (CAP) in infants aged below 2 years increases their risk for subsequent respiratory disease when between 2 and 5 years of age.

Main finding: The rate of chronic respiratory disorder from 2-5 years of age, reactive airway disease, and CAP hospitalization after 2 years of age was 2.4-fold (95% CI 2.1-2.6), 3.2-fold (95% CI 2.6-3.8), and 6.3-fold (95% CI 3.6-10.9) higher in patients with CAP vs. comparison patients.

Study details: The data come from a retrospective study including 1,343 infants less than 2 years of age who were hospitalized once or more for CAP and matched with 6,715 comparator infants with no evidence of pneumonia.

Disclosures: The study was sponsored by Pfizer Inc. Some of the authors declared being directly employed by Pfizer or another organization that received financial support from Pfizer.

Source: Lapidot R et al. Repir Med. 2021:106671 (Oct 27). Doi: 10.1016/j.rmed.2021.106671.

Key clinical point: Pneumonia Severity Index (PSI) and the confusion, urea, respiratory rate, and blood pressure (CURB)-65 score are as effective at predicting in-hospital mortality in patients with SARS-CoV-2 community-acquired pneumonia (CAP) as they are in those with non-SARS-CoV-2 CAP.

Main finding: The area under the receiver operating characteristic curve in patients with SARS-CoV-2 CAP and non-SARS-CoV-2 CAP for PSI was 0.82 (95% Bayesian credible interval [bCI] 0.78-0.86) and 0.79 (95% bCI 0.77-0.80) and that for CURB-65 was 0.79 (95% bCI 0.75-0.84) and 0.75 (95% bCI 0.73-0.77), respectively.

Study details: This was a secondary analysis of 8,081 patients from 2 population-based cohort studies, each of which included adults hospitalized for either SARS-CoV-2 CAP or non-SARS-CoV-2 CAP.

Disclosures: The study was supported by the Center for Excellence for Research in Infectious Diseases at the University of Louisville. None of the authors declared any potential conflict of interests.

Source: Bradley J et al. Chest. 2021 (Nov 2). Doi: 10.1016/j.chest.2021.10.031.

Key clinical point: Pneumonia Severity Index (PSI) and the confusion, urea, respiratory rate, and blood pressure (CURB)-65 score are as effective at predicting in-hospital mortality in patients with SARS-CoV-2 community-acquired pneumonia (CAP) as they are in those with non-SARS-CoV-2 CAP.

Main finding: The area under the receiver operating characteristic curve in patients with SARS-CoV-2 CAP and non-SARS-CoV-2 CAP for PSI was 0.82 (95% Bayesian credible interval [bCI] 0.78-0.86) and 0.79 (95% bCI 0.77-0.80) and that for CURB-65 was 0.79 (95% bCI 0.75-0.84) and 0.75 (95% bCI 0.73-0.77), respectively.

Study details: This was a secondary analysis of 8,081 patients from 2 population-based cohort studies, each of which included adults hospitalized for either SARS-CoV-2 CAP or non-SARS-CoV-2 CAP.

Disclosures: The study was supported by the Center for Excellence for Research in Infectious Diseases at the University of Louisville. None of the authors declared any potential conflict of interests.

Source: Bradley J et al. Chest. 2021 (Nov 2). Doi: 10.1016/j.chest.2021.10.031.

Key clinical point: Pneumonia Severity Index (PSI) and the confusion, urea, respiratory rate, and blood pressure (CURB)-65 score are as effective at predicting in-hospital mortality in patients with SARS-CoV-2 community-acquired pneumonia (CAP) as they are in those with non-SARS-CoV-2 CAP.

Main finding: The area under the receiver operating characteristic curve in patients with SARS-CoV-2 CAP and non-SARS-CoV-2 CAP for PSI was 0.82 (95% Bayesian credible interval [bCI] 0.78-0.86) and 0.79 (95% bCI 0.77-0.80) and that for CURB-65 was 0.79 (95% bCI 0.75-0.84) and 0.75 (95% bCI 0.73-0.77), respectively.

Study details: This was a secondary analysis of 8,081 patients from 2 population-based cohort studies, each of which included adults hospitalized for either SARS-CoV-2 CAP or non-SARS-CoV-2 CAP.

Disclosures: The study was supported by the Center for Excellence for Research in Infectious Diseases at the University of Louisville. None of the authors declared any potential conflict of interests.

Source: Bradley J et al. Chest. 2021 (Nov 2). Doi: 10.1016/j.chest.2021.10.031.

Key clinical point: In patients with moderately severe community-acquired pneumonia (CAP) who reached clinical stability after 3 days of antibiotic treatment, male sex and age were the main risk factors for treatment failure.

Main finding: After excluding the Pneumonia Severity Index score and urea level at day 0, male sex (odds ratio [OR] 1.92; 95% CI 1.08-3.49) and age per year (OR 1.02; 95% CI 1.00-1.05) showed a significant association with treatment failure at day 15.

Study details: This was a secondary analysis including 291 of the 310 patients from the Pneumonia Short Treatment trial who were hospitalized for moderately severe CAP and were clinically stable after 3 days of receiving β-lactams, which is when they were randomly assigned to receive oral amoxicillin-clavulanate or placebo for 5 further days.

Disclosures: The study was supported by the French Ministry of Health and DRCI of Versailles. Dr. Crémieux reported receiving grants from an additional source outside the study.

Source: Dinh A et al. JAMA Netw Open. 2021;4(10):e2129566 (Oct 15). Doi: 10.1001/jamanetworkopen.2021.29566.

Key clinical point: In patients with moderately severe community-acquired pneumonia (CAP) who reached clinical stability after 3 days of antibiotic treatment, male sex and age were the main risk factors for treatment failure.

Main finding: After excluding the Pneumonia Severity Index score and urea level at day 0, male sex (odds ratio [OR] 1.92; 95% CI 1.08-3.49) and age per year (OR 1.02; 95% CI 1.00-1.05) showed a significant association with treatment failure at day 15.

Study details: This was a secondary analysis including 291 of the 310 patients from the Pneumonia Short Treatment trial who were hospitalized for moderately severe CAP and were clinically stable after 3 days of receiving β-lactams, which is when they were randomly assigned to receive oral amoxicillin-clavulanate or placebo for 5 further days.

Disclosures: The study was supported by the French Ministry of Health and DRCI of Versailles. Dr. Crémieux reported receiving grants from an additional source outside the study.

Source: Dinh A et al. JAMA Netw Open. 2021;4(10):e2129566 (Oct 15). Doi: 10.1001/jamanetworkopen.2021.29566.

Key clinical point: In patients with moderately severe community-acquired pneumonia (CAP) who reached clinical stability after 3 days of antibiotic treatment, male sex and age were the main risk factors for treatment failure.

Main finding: After excluding the Pneumonia Severity Index score and urea level at day 0, male sex (odds ratio [OR] 1.92; 95% CI 1.08-3.49) and age per year (OR 1.02; 95% CI 1.00-1.05) showed a significant association with treatment failure at day 15.

Study details: This was a secondary analysis including 291 of the 310 patients from the Pneumonia Short Treatment trial who were hospitalized for moderately severe CAP and were clinically stable after 3 days of receiving β-lactams, which is when they were randomly assigned to receive oral amoxicillin-clavulanate or placebo for 5 further days.

Disclosures: The study was supported by the French Ministry of Health and DRCI of Versailles. Dr. Crémieux reported receiving grants from an additional source outside the study.

Source: Dinh A et al. JAMA Netw Open. 2021;4(10):e2129566 (Oct 15). Doi: 10.1001/jamanetworkopen.2021.29566.