| Title: |
Omadacycline for Community-acquired Bacterial Pneumonia (OPTIC-2): A Phase 3b Randomized, Double-blind, Multicenter, Controlled, Noninferiority Trial |
| Authors: |
File, T.; Kaye, K.S.; Ihor, S.; Hovbakh, I.; Katsarava, V.; Kirsch, C.; Soni, K.; Gupta, K.; Deck, D.; Manley, A.; Anastasiou, D.; Chitra, S.; Villano, S. |
| Source: |
American Journal of Respiratory and Critical Care Medicine ; volume 211, issue Supplement_1, page A7721-A7721 ; ISSN 1073-449X 1535-4970 |
| Publisher Information: |
Oxford University Press (OUP) |
| Publication Year: |
2025 |
| Description: |
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 randomized (intent-to-treat population: omadacycline, n=336; moxifloxacin, n=334) and 668 received treatment. Baseline characteristics were similar in both groups. Overall, mean age was 62.8 years; 48.2% were aged >65 years, and 76.1% of patients were PORT III. Omadacycline successfully met predefined noninferiority criteria (margin of 10%) for ECR and PTE endpoints (FIGURE 1). Outcomes were consistent across comorbidities and microbiologically evaluable groups. ECRs for pathogens listed in the omadacycline label were 84.6-100% for ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1164/ajrccm.2025.211.abstracts.a7721 |
| Availability: |
https://doi.org/10.1164/ajrccm.2025.211.abstracts.a7721; https://academic.oup.com/ajrccm/article-pdf/211/Supplement_1/A7721/67054231/ajrccm_211_abstracts_a7721.pdf |
| Rights: |
https://academic.oup.com/pages/standard-publication-reuse-rights |
| Accession Number: |
edsbas.ABF569A3 |
| Database: |
BASE |