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Monoclonal antibody holds promise for S. aureus pneumonia
NEW ORLEANS – Monoclonal antibody therapies have already upended treatment strategies in cancer, dermatology, and multiple inflammatory diseases, and infectious disease may be next.
That’s because , according to a new study. The monoclonal antibody attacks the alpha-toxin secreted by S. aureus, thereby helping to protect immune cells.
“We know S. aureus pneumonia is a big problem. There is a lot of antibiotic resistance, and that is why we need new treatments,” Celine Gonzalez, MD, of the Dupuytren Central University Hospital in Limoges, France, said in an interview.
“Animal studies have shown the monoclonal antibody seems to be useful. This is the first in-human study to use a monoclonal antibody to treat hospital-acquired pneumonia due to Staphylococcus aureus,” Dr. Gonzalez said in a late-breaking poster presentation at the annual meeting of the American Society for Microbiology.
Treatment started within 36 hours of onset of severe pneumonia. Severity was based on a mean PaO2/FiO2 of 147 and/or a need for catecholamine. Six cases of pneumonia were related to MRSA and the remaining 42 to methicillin-susceptible S. aureus. The mean APACHE II score was 18.7, the mean Clinical Pulmonary Infection Score was 9.6, and the mean Sequential Organ Failure Assessment score was 6.9.
Participants were recruited from 13 ICUs in four countries. About 80% of participants were men. Their mean age was 56 years, and mean body mass index was 29 kg/m2. Concurrent antibiotic treatment choice and duration were at the investigator’s discretion.
S. aureus infection was considered eradicated if a follow-up culture was negative, a result achieved by 63% of the 16 placebo patients and 75%-88% of the AR-301-dosage groups. Eradication was also based on observed clinical success in the absence of a confirmatory culture. This was achieved by 38% in the placebo group and 13%-25% of the monoclonal antibody cohorts. A total of seven placebo patients and 15 AR-301 patients met eradication by these criteria.
Side effects were primarily minor and transient, Dr. Gonzalez said. Of the 343 total adverse events reported, only 8 (2.3%) were considered treatment related, she added.
“In infectious disease, it’s the beginning” for monoclonal antibody therapy, Dr. Gonzalez said. “But, it appears to be the future because … it is a more specific treatment, and there is no resistance.”
The study suggests adjunctive treatment with AR-301 appears safe for treatment of hospital-acquired bacterial pneumonia, she noted. The next step will be to confirm the findings in a larger, follow-up study that includes more efficacy outcomes, Dr. Gonzalez added.
Dr. Gonzalez reported having no relevant disclosures. The study’s principle investigator is a scientific advisor for Aridis Pharmaceuticals, which is developing AR-301.
NEW ORLEANS – Monoclonal antibody therapies have already upended treatment strategies in cancer, dermatology, and multiple inflammatory diseases, and infectious disease may be next.
That’s because , according to a new study. The monoclonal antibody attacks the alpha-toxin secreted by S. aureus, thereby helping to protect immune cells.
“We know S. aureus pneumonia is a big problem. There is a lot of antibiotic resistance, and that is why we need new treatments,” Celine Gonzalez, MD, of the Dupuytren Central University Hospital in Limoges, France, said in an interview.
“Animal studies have shown the monoclonal antibody seems to be useful. This is the first in-human study to use a monoclonal antibody to treat hospital-acquired pneumonia due to Staphylococcus aureus,” Dr. Gonzalez said in a late-breaking poster presentation at the annual meeting of the American Society for Microbiology.
Treatment started within 36 hours of onset of severe pneumonia. Severity was based on a mean PaO2/FiO2 of 147 and/or a need for catecholamine. Six cases of pneumonia were related to MRSA and the remaining 42 to methicillin-susceptible S. aureus. The mean APACHE II score was 18.7, the mean Clinical Pulmonary Infection Score was 9.6, and the mean Sequential Organ Failure Assessment score was 6.9.
Participants were recruited from 13 ICUs in four countries. About 80% of participants were men. Their mean age was 56 years, and mean body mass index was 29 kg/m2. Concurrent antibiotic treatment choice and duration were at the investigator’s discretion.
S. aureus infection was considered eradicated if a follow-up culture was negative, a result achieved by 63% of the 16 placebo patients and 75%-88% of the AR-301-dosage groups. Eradication was also based on observed clinical success in the absence of a confirmatory culture. This was achieved by 38% in the placebo group and 13%-25% of the monoclonal antibody cohorts. A total of seven placebo patients and 15 AR-301 patients met eradication by these criteria.
Side effects were primarily minor and transient, Dr. Gonzalez said. Of the 343 total adverse events reported, only 8 (2.3%) were considered treatment related, she added.
“In infectious disease, it’s the beginning” for monoclonal antibody therapy, Dr. Gonzalez said. “But, it appears to be the future because … it is a more specific treatment, and there is no resistance.”
The study suggests adjunctive treatment with AR-301 appears safe for treatment of hospital-acquired bacterial pneumonia, she noted. The next step will be to confirm the findings in a larger, follow-up study that includes more efficacy outcomes, Dr. Gonzalez added.
Dr. Gonzalez reported having no relevant disclosures. The study’s principle investigator is a scientific advisor for Aridis Pharmaceuticals, which is developing AR-301.
NEW ORLEANS – Monoclonal antibody therapies have already upended treatment strategies in cancer, dermatology, and multiple inflammatory diseases, and infectious disease may be next.
That’s because , according to a new study. The monoclonal antibody attacks the alpha-toxin secreted by S. aureus, thereby helping to protect immune cells.
“We know S. aureus pneumonia is a big problem. There is a lot of antibiotic resistance, and that is why we need new treatments,” Celine Gonzalez, MD, of the Dupuytren Central University Hospital in Limoges, France, said in an interview.
“Animal studies have shown the monoclonal antibody seems to be useful. This is the first in-human study to use a monoclonal antibody to treat hospital-acquired pneumonia due to Staphylococcus aureus,” Dr. Gonzalez said in a late-breaking poster presentation at the annual meeting of the American Society for Microbiology.
Treatment started within 36 hours of onset of severe pneumonia. Severity was based on a mean PaO2/FiO2 of 147 and/or a need for catecholamine. Six cases of pneumonia were related to MRSA and the remaining 42 to methicillin-susceptible S. aureus. The mean APACHE II score was 18.7, the mean Clinical Pulmonary Infection Score was 9.6, and the mean Sequential Organ Failure Assessment score was 6.9.
Participants were recruited from 13 ICUs in four countries. About 80% of participants were men. Their mean age was 56 years, and mean body mass index was 29 kg/m2. Concurrent antibiotic treatment choice and duration were at the investigator’s discretion.
S. aureus infection was considered eradicated if a follow-up culture was negative, a result achieved by 63% of the 16 placebo patients and 75%-88% of the AR-301-dosage groups. Eradication was also based on observed clinical success in the absence of a confirmatory culture. This was achieved by 38% in the placebo group and 13%-25% of the monoclonal antibody cohorts. A total of seven placebo patients and 15 AR-301 patients met eradication by these criteria.
Side effects were primarily minor and transient, Dr. Gonzalez said. Of the 343 total adverse events reported, only 8 (2.3%) were considered treatment related, she added.
“In infectious disease, it’s the beginning” for monoclonal antibody therapy, Dr. Gonzalez said. “But, it appears to be the future because … it is a more specific treatment, and there is no resistance.”
The study suggests adjunctive treatment with AR-301 appears safe for treatment of hospital-acquired bacterial pneumonia, she noted. The next step will be to confirm the findings in a larger, follow-up study that includes more efficacy outcomes, Dr. Gonzalez added.
Dr. Gonzalez reported having no relevant disclosures. The study’s principle investigator is a scientific advisor for Aridis Pharmaceuticals, which is developing AR-301.
AT ASM MICROBE 2017
Key clinical point: A monoclonal antibody that neutralizes the alpha-toxin secreted by S. aureus appeared safe and effective in an early trial.
Major finding: AR-301 appeared safe, with 8 of 343 adverse events, or 2.3%, considered treatment related.
Data source: Randomized, double-blind, placebo-controlled, international study in 48 patients from 13 ICUs.
Disclosures: Dr. Gonzalez reported having no relevant disclosures. The study’s principle investigator is a scientific advisor for Aridis Pharmaceuticals, which is developing AR-301.
Rapid culture, stewardship improve S. aureus bacteremia outcomes
NEW ORLEANS – Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy that combines rapid blood cultures to speed diagnosis with antibiotic stewardship to guide treatment.
Many academic medical centers report improved outcomes with this approach. Now a study of 66 patients at a medium-sized hospital in rural North Dakota suggests this strategy translates well to the community hospital setting and can reduce mortality and 30-day readmission rates, and increase cost-effectiveness overall.
“I was pleased to see we were able to replicate the positive outcomes observed in studies from large tertiary care centers with our small cohort,” Marijo Roiko, PhD, microbiology program director for pathology and laboratory services at Altru Health System in Grand Forks, N.D., said in an interview.
Dr. Roiko and colleagues compared 33 patients diagnosed and treated prior to the strategy with 33 others following its implementation. A total of 13 patients, or 39% of each cohort, developed potentially fatal methicillin-resistant S. aureus (MRSA) bacteremia. Patients’ average age ranged from 60 to 64 years, and about two-thirds of each group were men.
The investigators reported that 30-day all-cause mortality decreased from 15.6% to 13.3% after the protocol. In addition, 30-day readmission rates decreased from 25% to 11% of the group diagnosed and managed with the new strategy. Dr. Roiko presented these and other findings from the chart review at the annual meeting of the American Society for Microbiology.
Overall, the average length of stay decreased from 13 days to 10 days among the patients with S. aureus bacteremia. Among the subgroup of patients with MRSA, the length of stay dropped from 15 to 12 days. Among those with methicillin-susceptible S. aureus infections, 11 days decreased to 9 days after institution of the protocol.
The researchers also looked at time to antibiotic deescalation, and the average time decreased from 3 days to 1 day with the new strategy.
“These results demonstrate the utility of rapid testing from positive blood cultures and antibiotic stewardship for patients with Staph. aureus bacteremia,” Dr. Roiko said.
In terms of return on investment, the estimated cost savings associated with the 3-day reduction in length of hospital stay was sufficient to cover the increased capital expenditures and reagent costs, the researchers found. They estimated these increased costs as $78,960, excluding ICU and ancillary charges. The approximate $4,290 saved per day multiplied by 33 patients means the new protocol saved a total of $141,570.
Traditionally, patients with a positive blood culture of S. aureus had a gram stain, followed by provider notification when positive. Targeted antibiotic therapy was either administered at this point or held for culture-based identification and susceptibility testing. In the new protocol, a rapid culture identification panel (FilmArray BCID) is added at the time of gram staining. Positive results are reported to both the provider and pharmacist. Targeted therapy is then either administered or held based on culture-based susceptibility testing (species identification is determined as needed).
The current study findings add to a literature already supporting use of rapid blood cultures and/or stewardship guidance to address S. aureus bacteremia in academic and tertiary care centers (J Clin Microbiol. 2016;54:2455-63; Clin Microbiol Infect. 2015;21:313-22, and Clin. Infect. Dis. 2015;61:1071-80.
Dr. Roiko had no relevant financial disclosures.
NEW ORLEANS – Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy that combines rapid blood cultures to speed diagnosis with antibiotic stewardship to guide treatment.
Many academic medical centers report improved outcomes with this approach. Now a study of 66 patients at a medium-sized hospital in rural North Dakota suggests this strategy translates well to the community hospital setting and can reduce mortality and 30-day readmission rates, and increase cost-effectiveness overall.
“I was pleased to see we were able to replicate the positive outcomes observed in studies from large tertiary care centers with our small cohort,” Marijo Roiko, PhD, microbiology program director for pathology and laboratory services at Altru Health System in Grand Forks, N.D., said in an interview.
Dr. Roiko and colleagues compared 33 patients diagnosed and treated prior to the strategy with 33 others following its implementation. A total of 13 patients, or 39% of each cohort, developed potentially fatal methicillin-resistant S. aureus (MRSA) bacteremia. Patients’ average age ranged from 60 to 64 years, and about two-thirds of each group were men.
The investigators reported that 30-day all-cause mortality decreased from 15.6% to 13.3% after the protocol. In addition, 30-day readmission rates decreased from 25% to 11% of the group diagnosed and managed with the new strategy. Dr. Roiko presented these and other findings from the chart review at the annual meeting of the American Society for Microbiology.
Overall, the average length of stay decreased from 13 days to 10 days among the patients with S. aureus bacteremia. Among the subgroup of patients with MRSA, the length of stay dropped from 15 to 12 days. Among those with methicillin-susceptible S. aureus infections, 11 days decreased to 9 days after institution of the protocol.
The researchers also looked at time to antibiotic deescalation, and the average time decreased from 3 days to 1 day with the new strategy.
“These results demonstrate the utility of rapid testing from positive blood cultures and antibiotic stewardship for patients with Staph. aureus bacteremia,” Dr. Roiko said.
In terms of return on investment, the estimated cost savings associated with the 3-day reduction in length of hospital stay was sufficient to cover the increased capital expenditures and reagent costs, the researchers found. They estimated these increased costs as $78,960, excluding ICU and ancillary charges. The approximate $4,290 saved per day multiplied by 33 patients means the new protocol saved a total of $141,570.
Traditionally, patients with a positive blood culture of S. aureus had a gram stain, followed by provider notification when positive. Targeted antibiotic therapy was either administered at this point or held for culture-based identification and susceptibility testing. In the new protocol, a rapid culture identification panel (FilmArray BCID) is added at the time of gram staining. Positive results are reported to both the provider and pharmacist. Targeted therapy is then either administered or held based on culture-based susceptibility testing (species identification is determined as needed).
The current study findings add to a literature already supporting use of rapid blood cultures and/or stewardship guidance to address S. aureus bacteremia in academic and tertiary care centers (J Clin Microbiol. 2016;54:2455-63; Clin Microbiol Infect. 2015;21:313-22, and Clin. Infect. Dis. 2015;61:1071-80.
Dr. Roiko had no relevant financial disclosures.
NEW ORLEANS – Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy that combines rapid blood cultures to speed diagnosis with antibiotic stewardship to guide treatment.
Many academic medical centers report improved outcomes with this approach. Now a study of 66 patients at a medium-sized hospital in rural North Dakota suggests this strategy translates well to the community hospital setting and can reduce mortality and 30-day readmission rates, and increase cost-effectiveness overall.
“I was pleased to see we were able to replicate the positive outcomes observed in studies from large tertiary care centers with our small cohort,” Marijo Roiko, PhD, microbiology program director for pathology and laboratory services at Altru Health System in Grand Forks, N.D., said in an interview.
Dr. Roiko and colleagues compared 33 patients diagnosed and treated prior to the strategy with 33 others following its implementation. A total of 13 patients, or 39% of each cohort, developed potentially fatal methicillin-resistant S. aureus (MRSA) bacteremia. Patients’ average age ranged from 60 to 64 years, and about two-thirds of each group were men.
The investigators reported that 30-day all-cause mortality decreased from 15.6% to 13.3% after the protocol. In addition, 30-day readmission rates decreased from 25% to 11% of the group diagnosed and managed with the new strategy. Dr. Roiko presented these and other findings from the chart review at the annual meeting of the American Society for Microbiology.
Overall, the average length of stay decreased from 13 days to 10 days among the patients with S. aureus bacteremia. Among the subgroup of patients with MRSA, the length of stay dropped from 15 to 12 days. Among those with methicillin-susceptible S. aureus infections, 11 days decreased to 9 days after institution of the protocol.
The researchers also looked at time to antibiotic deescalation, and the average time decreased from 3 days to 1 day with the new strategy.
“These results demonstrate the utility of rapid testing from positive blood cultures and antibiotic stewardship for patients with Staph. aureus bacteremia,” Dr. Roiko said.
In terms of return on investment, the estimated cost savings associated with the 3-day reduction in length of hospital stay was sufficient to cover the increased capital expenditures and reagent costs, the researchers found. They estimated these increased costs as $78,960, excluding ICU and ancillary charges. The approximate $4,290 saved per day multiplied by 33 patients means the new protocol saved a total of $141,570.
Traditionally, patients with a positive blood culture of S. aureus had a gram stain, followed by provider notification when positive. Targeted antibiotic therapy was either administered at this point or held for culture-based identification and susceptibility testing. In the new protocol, a rapid culture identification panel (FilmArray BCID) is added at the time of gram staining. Positive results are reported to both the provider and pharmacist. Targeted therapy is then either administered or held based on culture-based susceptibility testing (species identification is determined as needed).
The current study findings add to a literature already supporting use of rapid blood cultures and/or stewardship guidance to address S. aureus bacteremia in academic and tertiary care centers (J Clin Microbiol. 2016;54:2455-63; Clin Microbiol Infect. 2015;21:313-22, and Clin. Infect. Dis. 2015;61:1071-80.
Dr. Roiko had no relevant financial disclosures.
AT ASM MICROBE 2017
Key clinical point:
Major finding: 30-day mortality dropped from 15.6% prior to the protocol to 13.3% after implementation.
Data source: A retrospective comparison of 33 patients receiving traditional diagnosis and management versus 33 others with a new rapid blood culture and stewardship program approach.
Disclosures: Dr. Roiko had no relevant financial disclosures.