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

• Omadacycline (Drug): Omadacycline IV/PO
• Moxifloxacin (Drug): Moxifloxacin IV/PO

Primary outcomes

• Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population. [18 months]

Secondary outcomes

• 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]

Sex: All, ages: 18 Years to any

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.

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• Haihui Huang, PhD, Principal investigator, Huashan Hospital