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

• Status: Completed
• Trial end date: 2017-03-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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