Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)



Status:Completed
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:November 2015
End Date:March 10, 2017

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A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared
to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.


Inclusion Criteria:

- Patients, ages 18 years or older who have signed the informed consent

- Has qualifying bacterial pneumonia

- Female patients must not be pregnant at the time of enrollment

- Must agree to a reliable method of birth control during the study and for 30 days
following the last dose of study drug

Exclusion Criteria:

- Known or suspected hospital-acquired pneumonia

- Evidence of significant immunological disease

- Has a history of hypersensitivity or allergic reaction to any tetracycline or to any
fluoroquinolone antibiotic

- Has received an investigational drug within past 30 days

- Women who are pregnant or nursing
We found this trial at
13
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Zachary, LA
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Huntington, West Virginia 25701
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Ventura, CA
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