NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.

Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.

Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.

The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.

“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”

Dr. McCurdy reported having no disclosures.

[email protected]

NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.

Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.

Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.

The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.

“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”

Dr. McCurdy reported having no disclosures.

[email protected]

NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.

Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.

Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.

The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.

“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”

Dr. McCurdy reported having no disclosures.

[email protected]

In conjunction with the Centers for Disease Control & Prevention’s Get Smart about Antibiotics Week, SHM is committed to promoting improved antibiotic-prescribing behaviors among the nation’s hospitalists through its “Fight the Resistance” awareness campaign.

Display SHM’s three downloadable “Fight the Resistance” posters, available at www.fighttheresistance.org. Hang them in your break rooms, hallways, or other high-profile locations to help remind your colleagues about the dangers of antibiotic resistance. SHM will be launching a mentored implementation program on antibiotics in early 2017. To be notified when the program becomes available, visit www.hospitalmedicine.org/ABX16.

In conjunction with the Centers for Disease Control & Prevention’s Get Smart about Antibiotics Week, SHM is committed to promoting improved antibiotic-prescribing behaviors among the nation’s hospitalists through its “Fight the Resistance” awareness campaign.

Display SHM’s three downloadable “Fight the Resistance” posters, available at www.fighttheresistance.org. Hang them in your break rooms, hallways, or other high-profile locations to help remind your colleagues about the dangers of antibiotic resistance. SHM will be launching a mentored implementation program on antibiotics in early 2017. To be notified when the program becomes available, visit www.hospitalmedicine.org/ABX16.

In conjunction with the Centers for Disease Control & Prevention’s Get Smart about Antibiotics Week, SHM is committed to promoting improved antibiotic-prescribing behaviors among the nation’s hospitalists through its “Fight the Resistance” awareness campaign.

Display SHM’s three downloadable “Fight the Resistance” posters, available at www.fighttheresistance.org. Hang them in your break rooms, hallways, or other high-profile locations to help remind your colleagues about the dangers of antibiotic resistance. SHM will be launching a mentored implementation program on antibiotics in early 2017. To be notified when the program becomes available, visit www.hospitalmedicine.org/ABX16.

There is no better time than American Diabetes Month to learn more about SHM’s Glycemic Control Program. Find out how your institution can submit point-of-care data to SHM’s Data Center, generate monthly reports, and be included in the national glucometrics benchmark report. Hospital systems are also encouraged to subscribe in order to track their individual performance as well as compare overall performance.

View a recent case study on three sites that demonstrated more rapid definitive improvements in measurable outcomes with the mentoring program, driving change through ongoing objective support, data collection, and analysis. Don’t wait: Be one of the 100 hospitals nationwide supported by SHM’s respected Glycemic Control Program. Learn more at www.hospitalmedicine.org/gc.

There is no better time than American Diabetes Month to learn more about SHM’s Glycemic Control Program. Find out how your institution can submit point-of-care data to SHM’s Data Center, generate monthly reports, and be included in the national glucometrics benchmark report. Hospital systems are also encouraged to subscribe in order to track their individual performance as well as compare overall performance.

View a recent case study on three sites that demonstrated more rapid definitive improvements in measurable outcomes with the mentoring program, driving change through ongoing objective support, data collection, and analysis. Don’t wait: Be one of the 100 hospitals nationwide supported by SHM’s respected Glycemic Control Program. Learn more at www.hospitalmedicine.org/gc.

There is no better time than American Diabetes Month to learn more about SHM’s Glycemic Control Program. Find out how your institution can submit point-of-care data to SHM’s Data Center, generate monthly reports, and be included in the national glucometrics benchmark report. Hospital systems are also encouraged to subscribe in order to track their individual performance as well as compare overall performance.

View a recent case study on three sites that demonstrated more rapid definitive improvements in measurable outcomes with the mentoring program, driving change through ongoing objective support, data collection, and analysis. Don’t wait: Be one of the 100 hospitals nationwide supported by SHM’s respected Glycemic Control Program. Learn more at www.hospitalmedicine.org/gc.

Now through December 31, 2016, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:

• A $35 credit toward 2017–2018 dues when recruiting 1 new member.
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members.

For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.

Now through December 31, 2016, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:

• A $35 credit toward 2017–2018 dues when recruiting 1 new member.
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members.

For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.

Now through December 31, 2016, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:

• A $35 credit toward 2017–2018 dues when recruiting 1 new member.
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members.

For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.

Antihemophilic factor

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy.

Lonoctocog alfa is intended for the treatment and prophylaxis of bleeding in hemophilia A patients of all ages.

The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make a decision in the next few months.

Lonoctocog alfa is designed to provide lasting protection from bleeds with 2- to 3-times weekly dosing. The product uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of FVIII and provide longer-lasting FVIII activity.

Lonoctocog alfa is being developed by CSL Behring GmbH.

Clinical trials

The CHMP’s positive opinion of lonoctocog alfa is based on results from the AFFINITY clinical development program, which includes a trial of children (n=84) and a trial of adolescents and adults (n=175).

Among patients who received lonoctocog alfa prophylactically, the median annualized bleeding rate was 1.14 in the adults and adolescents and 3.69 in children younger than 12.

In all, there were 1195 bleeding events—848 in the adults/adolescents and 347 in the children.

Ninety-four percent of bleeds in adults/adolescents and 96% of bleeds in pediatric patients were effectively controlled with no more than 2 infusions of lonoctocog alfa weekly.

Eighty-one percent of bleeds in adults/adolescents and 86% of bleeds in pediatric patients were controlled by a single infusion.

Researchers assessed safety in 258 patients from both studies. Adverse reactions occurred in 14 patients and included hypersensitivity (n=4), dizziness (n=2), paresthesia (n=1), rash (n=1), erythema (n=1), pruritus (n=1), pyrexia (n=1), injection-site pain (n=1), chills (n=1), and feeling hot (n=1).

One patient withdrew from treatment due to hypersensitivity.

None of the patients developed neutralizing antibodies to FVIII or antibodies to host cell proteins. There were no reports of anaphylaxis or thrombosis.

Antihemophilic factor

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy.

Lonoctocog alfa is intended for the treatment and prophylaxis of bleeding in hemophilia A patients of all ages.

The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make a decision in the next few months.

Lonoctocog alfa is designed to provide lasting protection from bleeds with 2- to 3-times weekly dosing. The product uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of FVIII and provide longer-lasting FVIII activity.

Lonoctocog alfa is being developed by CSL Behring GmbH.

Clinical trials

The CHMP’s positive opinion of lonoctocog alfa is based on results from the AFFINITY clinical development program, which includes a trial of children (n=84) and a trial of adolescents and adults (n=175).

Among patients who received lonoctocog alfa prophylactically, the median annualized bleeding rate was 1.14 in the adults and adolescents and 3.69 in children younger than 12.

In all, there were 1195 bleeding events—848 in the adults/adolescents and 347 in the children.

Ninety-four percent of bleeds in adults/adolescents and 96% of bleeds in pediatric patients were effectively controlled with no more than 2 infusions of lonoctocog alfa weekly.

Eighty-one percent of bleeds in adults/adolescents and 86% of bleeds in pediatric patients were controlled by a single infusion.

Researchers assessed safety in 258 patients from both studies. Adverse reactions occurred in 14 patients and included hypersensitivity (n=4), dizziness (n=2), paresthesia (n=1), rash (n=1), erythema (n=1), pruritus (n=1), pyrexia (n=1), injection-site pain (n=1), chills (n=1), and feeling hot (n=1).

One patient withdrew from treatment due to hypersensitivity.

None of the patients developed neutralizing antibodies to FVIII or antibodies to host cell proteins. There were no reports of anaphylaxis or thrombosis.

Antihemophilic factor

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy.

Lonoctocog alfa is intended for the treatment and prophylaxis of bleeding in hemophilia A patients of all ages.

The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make a decision in the next few months.

Lonoctocog alfa is designed to provide lasting protection from bleeds with 2- to 3-times weekly dosing. The product uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of FVIII and provide longer-lasting FVIII activity.

Lonoctocog alfa is being developed by CSL Behring GmbH.

Clinical trials

The CHMP’s positive opinion of lonoctocog alfa is based on results from the AFFINITY clinical development program, which includes a trial of children (n=84) and a trial of adolescents and adults (n=175).

Among patients who received lonoctocog alfa prophylactically, the median annualized bleeding rate was 1.14 in the adults and adolescents and 3.69 in children younger than 12.

In all, there were 1195 bleeding events—848 in the adults/adolescents and 347 in the children.

Ninety-four percent of bleeds in adults/adolescents and 96% of bleeds in pediatric patients were effectively controlled with no more than 2 infusions of lonoctocog alfa weekly.

Eighty-one percent of bleeds in adults/adolescents and 86% of bleeds in pediatric patients were controlled by a single infusion.

Researchers assessed safety in 258 patients from both studies. Adverse reactions occurred in 14 patients and included hypersensitivity (n=4), dizziness (n=2), paresthesia (n=1), rash (n=1), erythema (n=1), pruritus (n=1), pyrexia (n=1), injection-site pain (n=1), chills (n=1), and feeling hot (n=1).

One patient withdrew from treatment due to hypersensitivity.

None of the patients developed neutralizing antibodies to FVIII or antibodies to host cell proteins. There were no reports of anaphylaxis or thrombosis.

Topical tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle, results of a phase IIa trial have shown.

Tofacitinib is a Janus kinase inhibitor that affects the interleukin (IL)–4, IL-5, and IL-31 signaling pathways, interfering with the immune response that leads to inflammation.

The study could mean “that inhibition of the JAK-STAT pathway may be a new therapeutic target for AD,” wrote the study’s lead author, Robert Bissonnette, MD, president of Innovaderm Research in Montreal. The study was published in the British Journal of Dermatology (2016 Nov;175[5]:902-11).

In the multicenter, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily, the study group achieved an 81.7% mean reduction in baseline Eczema Area and Severity Index (EASI) score, compared with 29.9% of controls over the 4-week study period (P less than .001). EASI scores in the study group were about 80% at a score of 50, 60% at a score of 75, and 40% at a score of 90.

By week 4, about three-quarters of the study group were either clear or almost clear of their skin condition, according to the physician global assessment scale, compared with 22% of controls (P less than .05).

There also was a rapid reduction in patient-reported pruritus in the tofacitinib group per the Itch Severity Item scale, compared with controls, at weeks 2 and 4 (P less than .001 for each time point).

Tolerability was similar across the study, and treatment-related adverse effects were mild, although 44% of the tofacitinib group did report experiencing some form of infection, infestation, or other complication. Two people in the study group dropped out because of the severity of their treatment-emergent adverse events. There were no reported severe or serious infections.

Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the study’s sponsor.

[email protected]

On Twitter @whitneymcknight

Topical tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle, results of a phase IIa trial have shown.

Tofacitinib is a Janus kinase inhibitor that affects the interleukin (IL)–4, IL-5, and IL-31 signaling pathways, interfering with the immune response that leads to inflammation.

The study could mean “that inhibition of the JAK-STAT pathway may be a new therapeutic target for AD,” wrote the study’s lead author, Robert Bissonnette, MD, president of Innovaderm Research in Montreal. The study was published in the British Journal of Dermatology (2016 Nov;175[5]:902-11).

In the multicenter, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily, the study group achieved an 81.7% mean reduction in baseline Eczema Area and Severity Index (EASI) score, compared with 29.9% of controls over the 4-week study period (P less than .001). EASI scores in the study group were about 80% at a score of 50, 60% at a score of 75, and 40% at a score of 90.

By week 4, about three-quarters of the study group were either clear or almost clear of their skin condition, according to the physician global assessment scale, compared with 22% of controls (P less than .05).

There also was a rapid reduction in patient-reported pruritus in the tofacitinib group per the Itch Severity Item scale, compared with controls, at weeks 2 and 4 (P less than .001 for each time point).

Tolerability was similar across the study, and treatment-related adverse effects were mild, although 44% of the tofacitinib group did report experiencing some form of infection, infestation, or other complication. Two people in the study group dropped out because of the severity of their treatment-emergent adverse events. There were no reported severe or serious infections.

Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the study’s sponsor.

[email protected]

On Twitter @whitneymcknight

Topical tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle, results of a phase IIa trial have shown.

Tofacitinib is a Janus kinase inhibitor that affects the interleukin (IL)–4, IL-5, and IL-31 signaling pathways, interfering with the immune response that leads to inflammation.

The study could mean “that inhibition of the JAK-STAT pathway may be a new therapeutic target for AD,” wrote the study’s lead author, Robert Bissonnette, MD, president of Innovaderm Research in Montreal. The study was published in the British Journal of Dermatology (2016 Nov;175[5]:902-11).

In the multicenter, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily, the study group achieved an 81.7% mean reduction in baseline Eczema Area and Severity Index (EASI) score, compared with 29.9% of controls over the 4-week study period (P less than .001). EASI scores in the study group were about 80% at a score of 50, 60% at a score of 75, and 40% at a score of 90.

By week 4, about three-quarters of the study group were either clear or almost clear of their skin condition, according to the physician global assessment scale, compared with 22% of controls (P less than .05).

There also was a rapid reduction in patient-reported pruritus in the tofacitinib group per the Itch Severity Item scale, compared with controls, at weeks 2 and 4 (P less than .001 for each time point).

Tolerability was similar across the study, and treatment-related adverse effects were mild, although 44% of the tofacitinib group did report experiencing some form of infection, infestation, or other complication. Two people in the study group dropped out because of the severity of their treatment-emergent adverse events. There were no reported severe or serious infections.

Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the study’s sponsor.

[email protected]

On Twitter @whitneymcknight

NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.

Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.

In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.

The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.

The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.

Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.

“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”

Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.

“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.

“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.

The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.

“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.

“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.

The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”

Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.

“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”

Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.

[email protected]

NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.

Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.

In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.

The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.

The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.

Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.

“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”

Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.

“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.

“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.

The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.

“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.

“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.

The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”

Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.

“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”

Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.

[email protected]

NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.

Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.

In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.

The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.

The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.

Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.

“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”

Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.

“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.

“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.

The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.

“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.

“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.

The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”

Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.

“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”

Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.

[email protected]

One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.

The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]
On Twitter @mitchelzoler

One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.

The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]
On Twitter @mitchelzoler

One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.

The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]
On Twitter @mitchelzoler

SAN FRANCISCO – As researchers have learned more about otitis media in the past decade, the guidelines have shifted accordingly for one of the most common conditions of childhood.

Yet some controversies remain, and the condition remains a challenge to properly identify, David Conrad, MD, of the University of California, San Francisco, said at the annual meeting of the American Academy of Pediatrics.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Complications and treatment

Ossicular erosion or tympanic membrane perforation are two complications; the latter’s rate is 5%-29% for untreated acute otitis media. It typically closes within hours to days, however, with a 95% closure rate within 4 weeks.

“The ear drum is pretty forgiving, pretty resilient, really,” Dr. Conrad said. The perforation occurs when pressure builds up and takes the path of least resistance through the drum, but that release of pressure also typically relieves the pain.

“Mastoiditis is one of the most feared complications, obviously,” Dr. Conrad noted, and it’s a clinical diagnosis that’s important to distinguish from mastoid effusion.

“Any child who has acute otitis media, and the middle ear fills up with fluid, which is under pressure, it will then migrate up the mastoid cavity; so, if you have an ear infection, you will have mastoid fluid – but that doesn’t necessarily mean you have mastoiditis,” he explained. “Mastoiditis is a very aggressive inflammatory process that destroys bone in the mastoid cavity. It’s often due to strep, and it’s usually a pyogenic organism that’s particularly virulent.”

Pus will then leak out from the mastoid cavity and form an abscess. If there is bone destruction, that is mastoiditis, which is treated with an ear tube or sometimes a mastoidectomy, in which a drill drains all the pus and other tissue.
 

Speech development and other controversies

Aside from the child’s pain, parental anxiety, and the other potential complications, researchers have learned more recently about speech delay with otitis media. The average child with recurrent otitis media or with otitis media with effusion will experience decreased hearing for about 3 or 4 months, which can affect speech, educational, and cognitive outcomes.

“If that process repeats itself, they could lose out on an entire year of not hearing well. It’s like walking around with an ear plug in,” Dr. Conrad said. It’s about a 25-35 dB hearing loss, he said, which can lead to trouble with speech discrimination, particularly with background noise, and can interfere with relationships with family, peers, and other adults.

Emerging data suggest educational difficulties, such as problems with reading comprehension, could result, and research is pivoting to look at potential cognitive development concerns, Dr. Conrad said.

“It has been noted that earlier onset of otitis media has a greater impact on educational and attention outcomes,” he said. Central auditory processing drives the development of the auditory cortex, and if that is impaired during a critical window of opportunity while synapses are forming, it could also have effects on speech.

“Otitis media and speech development is an area of controversy,” Dr. Conrad explained. Otitis media has been found to impact auditory processing skills, speech discrimination, auditory pattern recognition, and auditory temporal processing, “but there’s little evidence to support long-term language impairment,” he said.

But that’s being challenged now. Research in rats and cats in particular, however, has shown changes in the auditory cortex from ear infections.

“Most of the data are from animal models, and I think that will morph into more studies into educational outcomes in children who had a lot of ear infections when they were younger,” Dr. Conrad predicted.

Other areas of controversy relate to whether the use of the pneumococcal conjugate vaccine (PCV13), which has reduced ear infections, may have led to the rise of infections from Haemophilus influenzae and Moraxella catarrhalis, and what the duration of therapy should be for antibiotics.

If not doing watchful waiting, first-line treatment is amoxicillin or amoxicillin-clavulanate unless the child has a penicillin allergy, in which case cefdinir, cefuroxime, or cefpodoxime can be prescribed. After 48-72 hours of failed therapy, amoxicillin-clavulanate can be considered, or clindamycin or ceftriaxone, “obviously a popular option if the child has had multiple ear infections in the past month or so,” he said.

“If the child is older, we don’t treat as long,” Dr. Conrad noted. Current guidelines recommend a 10-day course if the infection resulted from strep, a 7-day or 10-day course in children aged 2-5 years, and a 5-7 day course for children older than 6 years.

Dr. Conrad reported no disclosures.

[email protected]

SAN FRANCISCO – As researchers have learned more about otitis media in the past decade, the guidelines have shifted accordingly for one of the most common conditions of childhood.

Yet some controversies remain, and the condition remains a challenge to properly identify, David Conrad, MD, of the University of California, San Francisco, said at the annual meeting of the American Academy of Pediatrics.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Complications and treatment

Ossicular erosion or tympanic membrane perforation are two complications; the latter’s rate is 5%-29% for untreated acute otitis media. It typically closes within hours to days, however, with a 95% closure rate within 4 weeks.

“The ear drum is pretty forgiving, pretty resilient, really,” Dr. Conrad said. The perforation occurs when pressure builds up and takes the path of least resistance through the drum, but that release of pressure also typically relieves the pain.

“Mastoiditis is one of the most feared complications, obviously,” Dr. Conrad noted, and it’s a clinical diagnosis that’s important to distinguish from mastoid effusion.

“Any child who has acute otitis media, and the middle ear fills up with fluid, which is under pressure, it will then migrate up the mastoid cavity; so, if you have an ear infection, you will have mastoid fluid – but that doesn’t necessarily mean you have mastoiditis,” he explained. “Mastoiditis is a very aggressive inflammatory process that destroys bone in the mastoid cavity. It’s often due to strep, and it’s usually a pyogenic organism that’s particularly virulent.”

Pus will then leak out from the mastoid cavity and form an abscess. If there is bone destruction, that is mastoiditis, which is treated with an ear tube or sometimes a mastoidectomy, in which a drill drains all the pus and other tissue.
 

Speech development and other controversies

Aside from the child’s pain, parental anxiety, and the other potential complications, researchers have learned more recently about speech delay with otitis media. The average child with recurrent otitis media or with otitis media with effusion will experience decreased hearing for about 3 or 4 months, which can affect speech, educational, and cognitive outcomes.

“If that process repeats itself, they could lose out on an entire year of not hearing well. It’s like walking around with an ear plug in,” Dr. Conrad said. It’s about a 25-35 dB hearing loss, he said, which can lead to trouble with speech discrimination, particularly with background noise, and can interfere with relationships with family, peers, and other adults.

Emerging data suggest educational difficulties, such as problems with reading comprehension, could result, and research is pivoting to look at potential cognitive development concerns, Dr. Conrad said.

“It has been noted that earlier onset of otitis media has a greater impact on educational and attention outcomes,” he said. Central auditory processing drives the development of the auditory cortex, and if that is impaired during a critical window of opportunity while synapses are forming, it could also have effects on speech.

“Otitis media and speech development is an area of controversy,” Dr. Conrad explained. Otitis media has been found to impact auditory processing skills, speech discrimination, auditory pattern recognition, and auditory temporal processing, “but there’s little evidence to support long-term language impairment,” he said.

But that’s being challenged now. Research in rats and cats in particular, however, has shown changes in the auditory cortex from ear infections.

“Most of the data are from animal models, and I think that will morph into more studies into educational outcomes in children who had a lot of ear infections when they were younger,” Dr. Conrad predicted.

Other areas of controversy relate to whether the use of the pneumococcal conjugate vaccine (PCV13), which has reduced ear infections, may have led to the rise of infections from Haemophilus influenzae and Moraxella catarrhalis, and what the duration of therapy should be for antibiotics.

If not doing watchful waiting, first-line treatment is amoxicillin or amoxicillin-clavulanate unless the child has a penicillin allergy, in which case cefdinir, cefuroxime, or cefpodoxime can be prescribed. After 48-72 hours of failed therapy, amoxicillin-clavulanate can be considered, or clindamycin or ceftriaxone, “obviously a popular option if the child has had multiple ear infections in the past month or so,” he said.

“If the child is older, we don’t treat as long,” Dr. Conrad noted. Current guidelines recommend a 10-day course if the infection resulted from strep, a 7-day or 10-day course in children aged 2-5 years, and a 5-7 day course for children older than 6 years.

Dr. Conrad reported no disclosures.

[email protected]

SAN FRANCISCO – As researchers have learned more about otitis media in the past decade, the guidelines have shifted accordingly for one of the most common conditions of childhood.

Yet some controversies remain, and the condition remains a challenge to properly identify, David Conrad, MD, of the University of California, San Francisco, said at the annual meeting of the American Academy of Pediatrics.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Complications and treatment

Ossicular erosion or tympanic membrane perforation are two complications; the latter’s rate is 5%-29% for untreated acute otitis media. It typically closes within hours to days, however, with a 95% closure rate within 4 weeks.

“The ear drum is pretty forgiving, pretty resilient, really,” Dr. Conrad said. The perforation occurs when pressure builds up and takes the path of least resistance through the drum, but that release of pressure also typically relieves the pain.

“Mastoiditis is one of the most feared complications, obviously,” Dr. Conrad noted, and it’s a clinical diagnosis that’s important to distinguish from mastoid effusion.

“Any child who has acute otitis media, and the middle ear fills up with fluid, which is under pressure, it will then migrate up the mastoid cavity; so, if you have an ear infection, you will have mastoid fluid – but that doesn’t necessarily mean you have mastoiditis,” he explained. “Mastoiditis is a very aggressive inflammatory process that destroys bone in the mastoid cavity. It’s often due to strep, and it’s usually a pyogenic organism that’s particularly virulent.”

Pus will then leak out from the mastoid cavity and form an abscess. If there is bone destruction, that is mastoiditis, which is treated with an ear tube or sometimes a mastoidectomy, in which a drill drains all the pus and other tissue.
 

Speech development and other controversies

Aside from the child’s pain, parental anxiety, and the other potential complications, researchers have learned more recently about speech delay with otitis media. The average child with recurrent otitis media or with otitis media with effusion will experience decreased hearing for about 3 or 4 months, which can affect speech, educational, and cognitive outcomes.

“If that process repeats itself, they could lose out on an entire year of not hearing well. It’s like walking around with an ear plug in,” Dr. Conrad said. It’s about a 25-35 dB hearing loss, he said, which can lead to trouble with speech discrimination, particularly with background noise, and can interfere with relationships with family, peers, and other adults.

Emerging data suggest educational difficulties, such as problems with reading comprehension, could result, and research is pivoting to look at potential cognitive development concerns, Dr. Conrad said.

“It has been noted that earlier onset of otitis media has a greater impact on educational and attention outcomes,” he said. Central auditory processing drives the development of the auditory cortex, and if that is impaired during a critical window of opportunity while synapses are forming, it could also have effects on speech.

“Otitis media and speech development is an area of controversy,” Dr. Conrad explained. Otitis media has been found to impact auditory processing skills, speech discrimination, auditory pattern recognition, and auditory temporal processing, “but there’s little evidence to support long-term language impairment,” he said.

But that’s being challenged now. Research in rats and cats in particular, however, has shown changes in the auditory cortex from ear infections.

“Most of the data are from animal models, and I think that will morph into more studies into educational outcomes in children who had a lot of ear infections when they were younger,” Dr. Conrad predicted.

Other areas of controversy relate to whether the use of the pneumococcal conjugate vaccine (PCV13), which has reduced ear infections, may have led to the rise of infections from Haemophilus influenzae and Moraxella catarrhalis, and what the duration of therapy should be for antibiotics.

If not doing watchful waiting, first-line treatment is amoxicillin or amoxicillin-clavulanate unless the child has a penicillin allergy, in which case cefdinir, cefuroxime, or cefpodoxime can be prescribed. After 48-72 hours of failed therapy, amoxicillin-clavulanate can be considered, or clindamycin or ceftriaxone, “obviously a popular option if the child has had multiple ear infections in the past month or so,” he said.

“If the child is older, we don’t treat as long,” Dr. Conrad noted. Current guidelines recommend a 10-day course if the infection resulted from strep, a 7-day or 10-day course in children aged 2-5 years, and a 5-7 day course for children older than 6 years.

Dr. Conrad reported no disclosures.

[email protected]

NEW ORLEANS – The investigational intravenous formulation of the neuraminidase inhibitor zanamivir appears to be a safe influenza treatment for hospitalized children and adolescents at high risk of complications who can’t tolerate enteral therapy, according to findings from an open-label, multicenter, phase II study.

In 71 such patients with laboratory-confirmed flu, who presented within 7 days of illness onset and who received intravenous zanamivir (IVZ) for 5-10 days, 72% experienced adverse events (AEs), 21% experienced serious adverse events, and 5 deaths occurred, but none were considered by the investigators to be attributable to IVZ, Jeffrey Blumer, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.

Rather, the adverse events were “fairly diverse. ... the kinds of things normally seen in critically ill pediatric populations,” he said.

The patients, who had a mean age of 7 years, were treated with IVZ doses selected to provide exposures comparable to 600 mg in adults – a dosage shown in prior studies to be safe and well-tolerated in adults. Patients aged 6 months to under age 6 years received twice-daily doses of 14 mg/kg, and those aged 6 years to less than 18 years received twice-daily doses of 12 mg/kg, not to exceed 600 mg. Doses were adjusted for renal function.

Patients were enrolled from five countries, and most (69%) had received prior treatment with oseltamivir. More than half (56%) had chronic medical conditions.

The median time from symptom onset to IVZ treatment was 4 days, Dr. Blumer of the University of Toledo (Ohio) said at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Infiltrate on chest x-ray was seen in 59% of patients, mechanical ventilation was required in 34% of patients, and extracorporeal membrane oxygenation was required in 6% of patients. Treatment in the intensive care unit was required in 65% of patients, and cumulative mortality was 4% at 14 days, and 7% at 28 days.

“Overall, the [IVZ] exposure and then the elimination profiles were consistent across the entire age cohort – unusual for most drugs, but it seemed to hold true, which makes zanamivir a lot easier for us to work with in pediatrics,” Dr. Blumer said.

While the numbers are small, exposure and response delineation didn’t seem to be impacted by mechanical ventilation, by extracorporeal membrane oxygenation, or by continuous renal replacement therapy, which is a good sign, he noted.

“So we generally had good, consistent experience here. ... Overall, 64 of the 71 patients survived, got better, left the ICU, and left the hospital,” Dr. Blumer said.

Of note, a treatment-emergent resistance substitution, E119G, was detected in a day 5 H1N1 isolate from an immunocompetent patient who improved clinically while on IVZ, he said, adding that no phenotype data were available as the sample could not be cultured.

The findings are important, because while zanamivir is currently labeled for patients older than 7 years, and the intravenous formulation currently in development has been shown to be safe for adults, there is a critical unmet need for an effective parenteral treatment for severe flu in children at high risk of complications who cannot tolerate enteral therapy.

“We need a drug that is available for the critically ill. We need a drug available for kids who are unable to take oral therapy, and for treatment of oseltamivir-resistant strains,” he said, adding that the current findings suggest that IVZ – with dose selection based on age, weight, and renal function – is a suitable treatment option for such patients.

“In conclusion, what we saw in this open-label trial was that the dose selection that we utilized gave us the kind of exposure we’d expect, and it seems it was an appropriate way to approach pediatric patients,” he said. “There wasn’t any safety signal attributable to the drug, and the overall pattern was more that of serious influenza, rather than of drug exposure.”

Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.

[email protected]

NEW ORLEANS – The investigational intravenous formulation of the neuraminidase inhibitor zanamivir appears to be a safe influenza treatment for hospitalized children and adolescents at high risk of complications who can’t tolerate enteral therapy, according to findings from an open-label, multicenter, phase II study.

In 71 such patients with laboratory-confirmed flu, who presented within 7 days of illness onset and who received intravenous zanamivir (IVZ) for 5-10 days, 72% experienced adverse events (AEs), 21% experienced serious adverse events, and 5 deaths occurred, but none were considered by the investigators to be attributable to IVZ, Jeffrey Blumer, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.

Rather, the adverse events were “fairly diverse. ... the kinds of things normally seen in critically ill pediatric populations,” he said.

The patients, who had a mean age of 7 years, were treated with IVZ doses selected to provide exposures comparable to 600 mg in adults – a dosage shown in prior studies to be safe and well-tolerated in adults. Patients aged 6 months to under age 6 years received twice-daily doses of 14 mg/kg, and those aged 6 years to less than 18 years received twice-daily doses of 12 mg/kg, not to exceed 600 mg. Doses were adjusted for renal function.

Patients were enrolled from five countries, and most (69%) had received prior treatment with oseltamivir. More than half (56%) had chronic medical conditions.

The median time from symptom onset to IVZ treatment was 4 days, Dr. Blumer of the University of Toledo (Ohio) said at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Infiltrate on chest x-ray was seen in 59% of patients, mechanical ventilation was required in 34% of patients, and extracorporeal membrane oxygenation was required in 6% of patients. Treatment in the intensive care unit was required in 65% of patients, and cumulative mortality was 4% at 14 days, and 7% at 28 days.

“Overall, the [IVZ] exposure and then the elimination profiles were consistent across the entire age cohort – unusual for most drugs, but it seemed to hold true, which makes zanamivir a lot easier for us to work with in pediatrics,” Dr. Blumer said.

While the numbers are small, exposure and response delineation didn’t seem to be impacted by mechanical ventilation, by extracorporeal membrane oxygenation, or by continuous renal replacement therapy, which is a good sign, he noted.

“So we generally had good, consistent experience here. ... Overall, 64 of the 71 patients survived, got better, left the ICU, and left the hospital,” Dr. Blumer said.

Of note, a treatment-emergent resistance substitution, E119G, was detected in a day 5 H1N1 isolate from an immunocompetent patient who improved clinically while on IVZ, he said, adding that no phenotype data were available as the sample could not be cultured.

The findings are important, because while zanamivir is currently labeled for patients older than 7 years, and the intravenous formulation currently in development has been shown to be safe for adults, there is a critical unmet need for an effective parenteral treatment for severe flu in children at high risk of complications who cannot tolerate enteral therapy.

“We need a drug that is available for the critically ill. We need a drug available for kids who are unable to take oral therapy, and for treatment of oseltamivir-resistant strains,” he said, adding that the current findings suggest that IVZ – with dose selection based on age, weight, and renal function – is a suitable treatment option for such patients.

“In conclusion, what we saw in this open-label trial was that the dose selection that we utilized gave us the kind of exposure we’d expect, and it seems it was an appropriate way to approach pediatric patients,” he said. “There wasn’t any safety signal attributable to the drug, and the overall pattern was more that of serious influenza, rather than of drug exposure.”

Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.

[email protected]

NEW ORLEANS – The investigational intravenous formulation of the neuraminidase inhibitor zanamivir appears to be a safe influenza treatment for hospitalized children and adolescents at high risk of complications who can’t tolerate enteral therapy, according to findings from an open-label, multicenter, phase II study.

In 71 such patients with laboratory-confirmed flu, who presented within 7 days of illness onset and who received intravenous zanamivir (IVZ) for 5-10 days, 72% experienced adverse events (AEs), 21% experienced serious adverse events, and 5 deaths occurred, but none were considered by the investigators to be attributable to IVZ, Jeffrey Blumer, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.

Rather, the adverse events were “fairly diverse. ... the kinds of things normally seen in critically ill pediatric populations,” he said.

The patients, who had a mean age of 7 years, were treated with IVZ doses selected to provide exposures comparable to 600 mg in adults – a dosage shown in prior studies to be safe and well-tolerated in adults. Patients aged 6 months to under age 6 years received twice-daily doses of 14 mg/kg, and those aged 6 years to less than 18 years received twice-daily doses of 12 mg/kg, not to exceed 600 mg. Doses were adjusted for renal function.

Patients were enrolled from five countries, and most (69%) had received prior treatment with oseltamivir. More than half (56%) had chronic medical conditions.

The median time from symptom onset to IVZ treatment was 4 days, Dr. Blumer of the University of Toledo (Ohio) said at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Infiltrate on chest x-ray was seen in 59% of patients, mechanical ventilation was required in 34% of patients, and extracorporeal membrane oxygenation was required in 6% of patients. Treatment in the intensive care unit was required in 65% of patients, and cumulative mortality was 4% at 14 days, and 7% at 28 days.

“Overall, the [IVZ] exposure and then the elimination profiles were consistent across the entire age cohort – unusual for most drugs, but it seemed to hold true, which makes zanamivir a lot easier for us to work with in pediatrics,” Dr. Blumer said.

While the numbers are small, exposure and response delineation didn’t seem to be impacted by mechanical ventilation, by extracorporeal membrane oxygenation, or by continuous renal replacement therapy, which is a good sign, he noted.

“So we generally had good, consistent experience here. ... Overall, 64 of the 71 patients survived, got better, left the ICU, and left the hospital,” Dr. Blumer said.

Of note, a treatment-emergent resistance substitution, E119G, was detected in a day 5 H1N1 isolate from an immunocompetent patient who improved clinically while on IVZ, he said, adding that no phenotype data were available as the sample could not be cultured.

The findings are important, because while zanamivir is currently labeled for patients older than 7 years, and the intravenous formulation currently in development has been shown to be safe for adults, there is a critical unmet need for an effective parenteral treatment for severe flu in children at high risk of complications who cannot tolerate enteral therapy.

“We need a drug that is available for the critically ill. We need a drug available for kids who are unable to take oral therapy, and for treatment of oseltamivir-resistant strains,” he said, adding that the current findings suggest that IVZ – with dose selection based on age, weight, and renal function – is a suitable treatment option for such patients.

“In conclusion, what we saw in this open-label trial was that the dose selection that we utilized gave us the kind of exposure we’d expect, and it seems it was an appropriate way to approach pediatric patients,” he said. “There wasn’t any safety signal attributable to the drug, and the overall pattern was more that of serious influenza, rather than of drug exposure.”

Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.

[email protected]