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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

NCT06162286 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-14

No results posted yet for this study

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

DRUG

Omadacycline

Omadacycline IV/PO

DRUG

Moxifloxacin

Moxifloxacin IV/PO

Sponsors & Collaborators

  • Zai Lab (Hong Kong), Ltd.

    lead INDUSTRY

Principal Investigators

  • Haihui Huang, PhD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2025-01-01
Completion
2025-11-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162286 on ClinicalTrials.gov