Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia. (March 2021)

• Record Type: Journal Article
• Authors: Torres, Antoni; Garrity-Ryan, Lynne; Kirsch, Courtney; Steenbergen, Judith N.; Eckburg, Paul B.; Das, Anita F.; Curran, Marla; Manley, Amy; Tzanis, Evan; McGovern, Paul C.
• Is Part Of: International journal of infectious diseases. Volume 104(2021)
• Page Start: 501
• Page End: 509
• Publication Date: 2021-03
• Subjects: Community-acquired bacterial pneumonia -- Omadacycline -- Moxifloxacin -- Antibiotic treatment -- PORT risk class; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2021.01.032
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: Omadacycline is non-inferior to moxifloxacin for investigator-assessed response at post-treatment evaluation. High rates of clinical success were reported in patients with Pneumonia Patient Outcomes Research Team risk class III and IV. Clinical success rates were similar between groups against identified pathogens. Clinical success rates were similar between groups across key patient subgroups. Abstract: Objective: Community-acquired bacterial pneumonia (CABP) is a major clinical burden worldwide. In the phase III OPTIC study (NCT02531438) in CABP, omadacycline was found to be non-inferior to moxifloxacin for investigator-assessed clinical response (IACR) at post-treatment evaluation (PTE, 5–10 days after last dose). This article reports the efficacy findings, as specified in the European Medicines Agency (EMA) guidance. Methods: Patients were randomized 1:1 to omadacycline 100 mg intravenously (every 12 h for two doses, then every 24 h) with optional transition to 300 mg orally after 3 days, or moxifloxacin 400 mg intravenously (every 24 h) with optional transition to 400 mg orally after 3 days. The total treatment duration was 7−14 days. The primary endpoint for EMA efficacy analysis was IACR at PTE in patients with Pneumonia Patient Outcomes Research Team (PORT) risk class III and IV. Results: In total, 660 patients were randomized as PORT risk class III and IV. Omadacycline was non-inferior to moxifloxacin at PTE. The clinical success rates were 88.4% and 85.2%, respectively [intent-to-treat population; difference 3.3; 97.5% confidence interval (CI) −2.7 to 9.3], and 92.5% and 90.5%, respectively (clinically evaluable population; difference 2.0; 97.5% CI 3.2–7.4). Clinical success rates with omadacycline and moxifloxacin were similar against identified pathogens and across key subgroups. Conclusions: Omadacycline was non-inferior to moxifloxacin for IACR at PTE, with high clinical success across pathogen types and patient subgroups.