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
A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-acquired Bacterial Pneumonia (CABP)
Zai Lab (Hong Kong), Ltd.
100 participants
Nov 17, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- Written and signed informed consent obtained before any protocol specific assessment is performed.
- Male or female, ages 18 years or older.
- Has at least 3 of the following symptoms:
- Cough
- Production of purulent sputum
- Dyspnea (shortness of breath)
- Chest pain
- 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 Criteria4
- 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 failure.
- Is known or suspected to have CABP caused by a pathogen that may be resistant to either test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens).
- \-
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Omadacycline IV/PO
Moxifloxacin IV/PO
Locations(40)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06162286