Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Paratek

Status and phase: Completed; Phase 3

Conditions: Bacterial Pneumonia; Community-acquired Pneumonia

Treatments: Drug: Moxifloxacin; Drug: Omadacycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT04779242

PTK0796-CABP-19302

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: 670 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects, age 18 or older who have signed the informed consent form
• Must have a qualifying community-acquired bacterial pneumonia
• Subjects must not be pregnant or nursing 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
• Confirmed or suspected SARS-CoV-2 infection
• Evidence of significant immunological disease
• Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
• Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
• Has received an investigational drug within the past 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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670 participants in 2 patient groups

Omadacycline

Experimental group

Description:

Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.

Treatment:

Drug: Omadacycline

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration

Treatment:

Drug: Moxifloxacin