International Journal of Infectious Diseases (Mar 2021)

Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia

  • Antoni Torres,
  • Lynne Garrity-Ryan,
  • Courtney Kirsch,
  • Judith N. Steenbergen,
  • Paul B. Eckburg,
  • Anita F. Das,
  • Marla Curran,
  • Amy Manley,
  • Evan Tzanis,
  • Paul C. McGovern

Journal volume & issue
Vol. 104
pp. 501 – 509

Abstract

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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.

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