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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2023-11-17 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 failure. 2. 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). 3. Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess. \-
Contact & Investigator
Haihui Huang, PhD
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT06162286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Community-acquired Bacterial Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06162286 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT06162286 currently recruiting?
Yes, NCT06162286 is actively recruiting participants. Contact the research team at harriet.li@zailaboratory.com for enrollment information.
Where is the NCT06162286 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Bengbu, China, Changsha, China and 11 additional locations.
Who is sponsoring the NCT06162286 clinical trial?
NCT06162286 is sponsored by Zai Lab (Hong Kong), Ltd.. The principal investigator is Haihui Huang, PhD at Huashan Hospital. The trial plans to enroll 100 participants.