Status:
RECRUITING
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
Lead Sponsor:
Zai Lab (Hong Kong), Ltd.
Conditions:
Community-acquired Bacterial Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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).
- Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess.
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Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06162286
Start Date
November 17 2023
End Date
November 30 2025
Last Update
June 14 2024
Active Locations (40)
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1
Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
Beijing, China
2
Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department
Beijing, China
3
The First Affiliated Hospital of Bengbu Medical College/Intensive care unit
Bengbu, China
4
The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
Changsha, China