Beyond traditional tetracyclines: a real-world evaluation of effectiveness and safety of omadacycline therapy for complex bacterial infections
Abstract
Background: Omadacycline (OMC) is an aminomethylcycline antibiotic approved in 2018 for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults. This study assessed the effectiveness and safety of OMC in real-world clinical settings across the United States.
Methods: We conducted a multicenter, retrospective cohort study at 12 U.S. medical centers including adults who received OMC between October 2018 and October 2023. The primary outcome for definitive therapy was clinical cure, defined as resolution of infectious signs and symptoms without the need for alternative therapy due to concern for failure. For suppressive therapy, the primary outcome was breakthrough infection within 90 days, defined as recurrence with the same pathogen at the same site. Secondary outcomes included 30-day survival, recurrence, readmission, and adverse effects (AEs).
Results: Eighty-six patients were included; median (interquartile range [IQR]) age was 63 years (46.0-66.0), 52.3% were male, and 67.4% were white. Most received outpatient therapy (84.9%). The median Charlson Comorbidity Index was 8.5. Common infections included osteomyelitis (30.2%) and skin/soft tissue infections (27.9%). OMC was used as targeted therapy in 69.8% and as suppressive therapy in 30.2%. Clinical cure was achieved in 81.7%, and 30-day survival was 95.3%. Microbiologic recurrence occurred in 10.3% and breakthrough infection in 15.4%. AEs were reported in…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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