Status:
COMPLETED
Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
Lead Sponsor:
Paratek Pharmaceuticals Inc
Conditions:
Community-acquired Pneumonia
Bacterial Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT04779242
Start Date
February 25 2021
End Date
March 27 2024
Last Update
April 9 2025
Active Locations (55)
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1
Site 210
Gabrovo, Bulgaria
2
Site 213
Lom, Bulgaria
3
Site 208
Pernik, Bulgaria
4
Site 201
Pleven, Bulgaria