Omadacycline for Community-acquired Bacterial Pneumonia (OPTIC-2): A Phase 3b Randomized, Double-blind, Multicenter, Controlled, Noninferiority Trial
Abstract
Abstract RATIONALE: Omadacycline is an FDA-approved intravenous (IV) and oral (PO) treatment for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin-structure infections. METHODS: Conducted as part of postmarketing regulatory commitments, this phase 3b, double-blind, global study compared omadacycline versus moxifloxacin for the treatment of adults with CABP (PORT Risk Class III or IV; NCT04779242). Patients with known COVID-19 were excluded. Treatment was either omadacycline 100 mg IV q12h × 2 doses (or 200 mg IV once) on Day 1, thereafter 100 mg IV q24h; or moxifloxacin 400 mg IV q24h. After ≥2 days’ IV treatment, patients could transition to PO therapy (omadacycline 300 mg q24h or moxifloxacin 400 mg q12h); total treatment duration was 7-10 days (up to 14 days if baseline bacteremia). The primary endpoint, early clinical response (ECR; 72-120 hours after first dose), was defined as survival, no receipt of rescue antibacterial therapy, and improvement in ≥2 of 4 symptoms (cough, sputum production, pleuritic chest pain, dyspnea) without deterioration in any of these symptoms. Secondary endpoints included investigator's assessment of clinical response at end of treatment (EOT; 0-2 days after last dose) and post-therapy evaluation (PTE; 5-10 days after last dose), defined as survival with resolution of signs and symptoms of infection such that further antibacterial therapy was unnecessary. RESULTS: From 2021 to 2024, 670 patients were…
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: 336 participants or records.
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