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

Paratek

Status and phase: Completed; Phase 3

Conditions: Bacterial Pneumonia; Community-Acquired Infections

Treatments: Drug: Omadacycline; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531438

PTK0796-CABP-1200

Details and patient eligibility

About

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.

Enrollment: 774 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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774 participants in 2 patient groups

Omadacycline

Experimental group

Description:

Omadacycline IV; Omadacycline tablets

Treatment:

Drug: Omadacycline

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin IV; Moxifloxacin tablets

Treatment:

Drug: Moxifloxacin