Overview
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
Inclusion Criteria:
- 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 Criteria:
- 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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