P-618. Pooled Microbiological Outcomes from the Phase 3, Randomized OPTIC and OPTIC-2 Trials of Omadacycline vs Moxifloxacin in Community-acquired Bacterial Pneumonia
Abstract
Abstract Background Omadacycline (OMC) is an FDA-approved oral (PO) and intravenous (IV) treatment for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin-structure infections. We present pooled efficacy and microbiological response of OMC vs moxifloxacin (MOX) from two CABP phase 3 trials.Figure 1. OPTIC and OPTIC-2 Study Designs. OPTIC: treatment was either OMC 100 mg IV q12h ×2 doses or 200 mg IV once per day on day 1, thereafter 100 mg IV q24h; or MOX 400 mg IV q24h for 3 days. OPTIC-2: OMC 100 mg IV q12h x2 doses or 200 mg IV once per day, or MOX 400 mg IV q24h on days 1-2. Thereafter, patients could transition to PO therapy (OMC 300 mg q24h or MOX 400 mg q24h) Total treatment duration was 7 to 14 days for OPTIC, and 7 to 10 days for OPTIC-2 with the option to extend to 14 days if the participant had bacteremia at baseline. Early clinical response (ECR; 72–120 h after first dose) was defined as survival, no receipt of rescue antibacterial therapy, and improvement in at least two of four 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.Table 1. Demographic…
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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: 762 participants or records.
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