Omadacycline versus moxifloxacin for community-acquired bacterial pneumonia (OPTIC-2): a phase 3b, randomised, double-blind, multicentre, controlled, noninferiority trial
Abstract
Summary Background Omadacycline is a first-in-class aminomethylcycline antibiotic approved to treat adults with community-acquired bacterial pneumonia (CABP). This trial was conducted as a postmarketing regulatory commitment to confirm the efficacy and safety of omadacycline. Methods This phase 3b, randomised, double-blind, multicentre, noninferiority trial enrolled adults in Eastern Europe between February 2021 (first patient enrolled) and March 2024 (last patient follow-up visit) who had CABP (NCT04779242). Participants with Pneumonia Severity Index (PSI) class III or IV CABP were randomised 1:1 to omadacycline (100 mg IV every 12 h for two doses, then 100 mg IV QD) or moxifloxacin (400 mg IV QD), with an oral option after ≥2 days of treatment (omadacycline, 300 mg QD; or moxifloxacin, 400 mg QD), for a total of 7–10 days. Primary efficacy endpoint was early clinical response (ECR), assessed 72–120 h after first dose, with a noninferiority margin of 10%. Key secondary endpoint was investigator's assessment of clinical response at post-therapy evaluation (PTE), 5–10 days after last dose. Microbiological response was determined by subject and pathogen. Treatment-emergent adverse events (TEAEs) were reported through 30–37 days after first dose. Findings Of 670 participants randomised (omadacycline, n = 336; moxifloxacin, n = 334), approximately half were aged >65 years, and 76% had PSI class III disease. Omadacycline was noninferior to moxifloxacin at ECR and PTE (ECR, 89.6%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 670 participants or records.
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