Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
- Conditions
- Community-acquired PneumoniaBacterial Pneumonia
- Registration Number
- NCT04779242
- Lead Sponsor
- Paratek Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 670
Inclusion Criteria:<br><br> - Male or female subjects, age 18 or older who have signed the informed consent form<br><br> - Must have a qualifying community-acquired bacterial pneumonia<br><br> - Subjects must not be pregnant or nursing at the time of enrollment<br><br> - Must agree to a reliable method of birth control during the study and for 30 days<br> following the last dose of study drug<br><br>Exclusion Criteria:<br><br> - Known or suspected hospital-acquired pneumonia<br><br> - Confirmed or suspected SARS-CoV-2 infection<br><br> - Evidence of significant immunological disease<br><br> - Has a life expectancy of less than or equal to 3 months or any concomitant condition<br> that is likely to interfere with evaluation of the response of the infection under<br> study, determination of AEs, or completion of the expected course of treatment<br><br> - Has a history of contraindications, hypersensitivity, or allergic reaction to any<br> tetracycline or fluoroquinolone antibiotic<br><br> - Has received an investigational drug within the past 30 days
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with early clinical response in the Intent-to-Treat (ITT) Population at the Early Clinical Response (ECR) visit
- Secondary Outcome Measures
Name Time Method Number of participants with the indicated investigator assessment of clinical response in the Intent-to-Treat (ITT) Population at the Post Therapy Evaluation (PTE) Visit;Number of participants with the indicated investigator assessment of clinical response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the Post-Therapy Evaluation (PTE) Visit