Community-acquired Bacterial Pneumonia
Conditions
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.
Interventions
DRUGOmadacycline
Omadacycline IV/PO
DRUGMoxifloxacin
Moxifloxacin IV/PO
Sponsors
Zai Lab (Hong Kong), Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate at the Early Clinical Response (ECR) assessment (72 to 120 hours after administration of the first dose of test article) in the mITT population. | 72 to 120 hours |
| Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population. | 18 months |
Countries
China
Contacts
Primary ContactHarriet Li
Outcome results
None listed