Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia (NCT04779242) | Clinical Trial Compass
CompletedPhase 3
Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
Bulgaria670 participantsStarted 2021-02-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit
Timeframe: 72 to 120 hours after the first dose of test article