Omadacycline versus moxifloxacin for community-acquired bacterial pneumonia (OPTIC-2): a phase 3b, randomised, double-blind, multicentre, controlled, noninferiority trial.

ABSTRACT:

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 moxiflox

SUBMITTER: File TM 

PROVIDER: S-EPMC12670926 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature