NCT06162286 A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP
| NCT ID | NCT06162286 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zai Lab (Hong Kong), Ltd. |
| Condition | Community-acquired Bacterial Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2025-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.
Eligibility Criteria
Inclusion Criteria: 1. Written and signed informed consent obtained before any protocol specific assessment is performed. 2. Male or female, ages 18 years or older. 3. Has at least 3 of the following symptoms: * Cough * Production of purulent sputum * Dyspnea (shortness of breath) * Chest pain 4. Has at least 2 of the following abnormal vital signs: * Fever or hypothermia documented by the investigator (temperature \> 38.0°C or \< 36.0°C) * Hypotension with systolic blood pressure (SBP) \< 90 mmHg * Heart rate (HR) \> 90 beats per minute (bpm) * Respiratory rate (RR) \> 20 breaths/minute Exclusion Criteria: 1. Has received antibacterial treatment \>24hr within the 72hr window prior to randomization. Subjects may be eligible despite prior antibacterial therapy if they had been treated with short action time antimicrobial for ≤24h, or if they have received \> 48 hours of prior systemic antibacterial therapy for the current episode of CABP with unequivocal clinical evidence of treatment f