An antibiotic that has shown effectiveness for bacterial pneumonia also appears successful in fighting methicillin-resistant staph infections, reports a team led by Duke Health.
The drug, ceftobiprole, showed similar benefit when tested against the antibiotic daptomycin to treat complicated Staphylococcus aureus bacterial infections. If approved by the FDA, ceftobiprole could provide another line of defense against a common and often deadly bacterial infection.
“This is an area of true need,” said Thomas Holland, M.D., DCRI faculty member, associate professor in the Department of Medicine at Duke University School of Medicine and chair of the data review committee of the study appearing online Sept. 27 in the New England Journal of Medicine and published in the Oct. 12, 2023 edition of the NEJM. “There has not been a new antibiotic approved for the treatment of S. aureus bacteremia for over 15 years.”
The study, called ERADICATE, enrolled 390 patients with complicated staph infections at 60 sites in 17 countries from August 2018 through March 2022. Roughly half were randomly assigned to receive infusions of ceftobiprole and the other half were treated intravenously with daptomycin. The Duke Clinical Research Institute’s Clinical Events Classification group ran the adjudication committee for the trial.
The primary outcome was overall treatment success, which required survival, clearance of the bacteria from the bloodstream, symptom improvement, and no new bacterial complications 70 days after treatment. Safety was also assessed.
The study found that both antibiotics performed similarly. Of the ceftobiprole group, 69.8% of patients experienced overall success, compared to 68.7% in the daptomycin group. Both drugs were also similarly tolerated, with gastrointestinal issues being the most common side effect.
“Despite a lot of work in medical science, complicated staph infections still have a 25% mortality rate at 90 days,” said study co-author Vance G. Fowler, Jr., professor in Duke’s departments of Medicine and Molecular Genetics & Microbiology. “We need more options for treating these infections.”
In addition to Holland and Fowler, study authors include Sara E. Cosgrove, Sarah B. Doernberg, Timothy C. Jenkins, Nicholas A. Turner, Helen W. Boucher, Oleksander Pavlov, Ivan Titov, Serhii Kosulnykov, Boyko Atanasov, Ivan Poromanski, Manana Makhviladze, Anastasia Anderzhanova, Martin E. Stryjewski, Maziar Assadi Gehr, Marc Engelhardt, Kamal Hamed, Daniel Ionescu, Mark Jones, Mikael Saulay, Jennifer Smart, and Harald Seifert on behalf of the ERADICATE Study Group.
The study was sponsored by Basilea Pharmaceutica International Ltd., which markets ceftobiprole. It was funded by the Department of Health and Human Services, Office of the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority (HHSO100201600002C).