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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zai Lab (Hong Kong), Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Community-acquired Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Omadacycline	Omadacycline IV/PO
DRUG	Moxifloxacin	Moxifloxacin IV/PO

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-01-01
• Completion: 2025-11-30
• First posted: 2023-12-08
• Last updated: 2024-06-14

Locations

40 sites across 1 country: China

Regulatory

• FDA-regulated drug study