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

Study Overview
=================
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.

Official Title
-----------------
A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-acquired Bacterial Pneumonia (CABP)

Conditions
-----------------
Community-acquired Bacterial Pneumonia

Intervention / Treatment
-----------------
* Drug: Omadacycline
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moxifloxacin<br>Moxifloxacin IV/PO | Drug: Moxifloxacin<br>* Moxifloxacin IV/PO<br>|
| Experimental: Omadacycline<br>Omadacycline IV/PO | Drug: Omadacycline<br>* Omadacycline IV/PO<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |