Announcement

Collapse
No announcement yet.

CIDRAP- NEWS BRIEFS October 10, 2024

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • CIDRAP- NEWS BRIEFS October 10, 2024

    https://www.cidrap.umn.edu/all-news

    Phase 3 data support use of combination antibiotic for multidrug-resistant infections



    News brief

    October 9, 2024
    Chris Dall, MA
    Topics

    Antimicrobial Stewardship

    An international team of investigators this week published phase 3 clinical trial data supporting aztreonam-avibactam as a potential therapeutic option for patients with serious gram-negative bacterial infections with limited treatment options.

    Jointly developed by Pfizer and Abbvie, aztreonam-avibactam is a beta-lactam/beta-lactamase inhibitor combination that restores aztreonam's activity against gram-negative bacteria that carry two defense mechanisms—metallo-beta-lactamase (MBL) and beta-lactamase enzymes—that confer resistance to nearly all currently available antibiotics. It was approved in April by the European Medicines Agency based on the results of two phase 3 clinical trials that evaluated its efficacy in treating several types of multidrug-resistant infections.

    The results of the open-label REVISIT trial, published in The Lancet Infectious Diseases, show that aztreonam-avibactam had similar clinical cure rates as meropenem in 422 patients with either complicated intra-abdominal infection (76.4% vs 74.0%, respectively) or hospital-acquired/ventilator-associated pneumonia (HAP-VAP) (45.9% vs 41.7%) caused by gram-negative bacteria. The investigators also found that overall all-cause mortality rates at 28 days were relatively low, and similar between both treatment groups for each infection type (2% for aztreonam-avibactam vs 3% for meropenem in patients with complicated intra-abdominal infection and 11% vs 19% in patients with HAP-VAP).

    Aztreonam-avibactam was generally well-tolerated, with safety findings that were consistent with the known safety profile of aztreonam.

    "These phase 3 efficacy and safety data provide support for aztreonam-avibactam as a potential therapeutic option for complicated intra-abdominal infection or HAP-VAP caused by Gram-negative bacteria," the investigators wrote.

    Trial limitations


    The investigators add, however, that while the trial was conducted in a region where MBL-producing gram-negative pathogens are prevalent, few patients in the trial had infections caused by MBL-producing bacteria, highlighting the need for more data on the drug's efficacy against such pathogens. That concern is echoed in a commentary by infectious disease experts from the University of Maryland School of Pharmacy and the University of Pittsburgh.

    "Ultimately, the small number of patients with metallo-β-lactamases in the study restricts the ability to draw conclusions about the utility of aztreonam-avibactam in eradicating these difficult-to-treat pathogens," Emily Heil, PharmD, and Erin McCreary, PharmD wrote.


    Penicillin allergies pose problem for nursing home residents, study suggests


    News brief

    October 9, 2024
    Chris Dall, MA
    Topics

    Antimicrobial Stewardship

    A study of long-term care (LTC) facilities in Massachusetts found that residents with a documented penicillin allergy were 95% less likely to receive beta-lactam antibiotics, researchers reported yesterday in Antimicrobial Stewardship & Healthcare Epidemiology.

    For the study, researchers from Tufts University and the Massachusetts Department of Public Health analyzed data on antibiotic prescriptions and penicillin allergies at 20 LTC facilities across the state. The aim of the study was to measure the impact of documented penicillin allergies on the prescribing patterns of beta-lactam antibiotics in LTC facilities, where an estimated 50% to 75% of residents receive at least on antibiotic annually. Previous research has shown that penicillin allergy labels are frequently inaccurate and can result in the selection of broader-spectrum antibiotics, which contribute to antimicrobial resistance and have an increased risk of side effects.

    "Inaccurate penicillin allergy labeling poses a critical health threat in this vulnerable population because older individuals are more susceptible to mortality from multidrug-resistant infections and adverse effects from broad-spectrum antibiotics," the study authors wrote.

    Penicillin allergy delabeling efforts needed in LTCs


    Among 2,345 LTC residents, 449 (19.1%) received an antibiotic, and 156 of the antibiotic recipients (34.7%) had a documented penicillin allergy. The primary indications for antibiotic prescriptions were urinary tract infections (UTIs) (45.4%), respiratory tract infections (RTIs) (29.2%), and skin and soft-tissue infections (SSTIs) (18.5%). Beta-lactams accounted for 45.5% of all antibiotic prescriptions.

    Inaccurate penicillin allergy labeling poses a critical health threat in this vulnerable population because older individuals are more susceptible to mortality from multidrug-resistant infections and adverse effects from broad-spectrum antibiotics.

    Multivariable regression analysis revealed that residents with a documented penicillin allergy were significantly less likely to be receiving beta-lactam antibiotics for all infections (adjusted odds ratio [aOR], 0.05; 95% confidence interval [CI], 0.03 to 0.09), UTIs (aOR, 0.03; 95% CI, 0.01 to 0.08), RTIs (aOR, 0.05; 95% CI, 0.02 to 0.13), and SSTIs (aOR, 0.11; 95% CI 0.03 to 0.38).

    The authors say the findings underscore the need to improve penicillin allergy assessments and delabeling strategies in LTC settings.


    GSK RSV vaccine data suggest protection across 3 seasons


    News brief

    October 9, 2024
    Lisa Schnirring
    Topics

    Respiratory Syncytial Virus (RSV)
    GSK yesterday announced new data from an ongoing phase 3 trial that indicates a single dose of its respiratory syncytial virus (RSV) vaccine Arexvy is protective across three seasons, even in people at increased risk for virus complications.

    In a statement, the company said the study group includes adults ages 60 and older. After three RSV seasons, the company said cumulative protection after a single dose was still meaningful, with an efficacy of 62.9% against lower respiratory tract disease (LRTD) caused by RSV and 67.9% against severe disease when compared with placebo. For the third season, efficacy was 48% against RSV-related LRTD.

    The company said the results suggest efficacy against different RSV subtypes in adults ages 70 to 79 years old and patients who have underlying medical conditions. It added that the cumulative efficacy findings give health providers the flexibility to vaccinate patients against RSV all year round.

    Revaccination might be needed to maintain protection


    However, over time, revaccination may be needed to maintain optimal protection, the company said. “GSK will continue to share efficacy and immune response data, including on revaccination, with recommending bodies to inform decisions on immunisation schedules and future revaccination.”

    Arexvy was first approved for adults ages 60 and older in the fall of 2023. In June the Food and Drug Administration expanded the age indication to adults ages 50 to 59 who are at increased risk of RSV complications.

    ALL BRIEFS
Working...
X