At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 774 enrolled
Drug / intervention
Omadacycline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia
In Brief
A Phase 3 clinical trial evaluating Omadacycline and Moxifloxacin for Bacterial Pneumonia and Community-Acquired Infections. Completed, enrolled 774 participants across 140 sites in 25 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Pneumonia, Community-Acquired Infections
CountriesBelgium, Brazil, Bulgaria, Croatia, Czechia, Georgia, Germany, Greece, Hungary, Israel, Latvia, Mexico, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartNov 2015
Primary CompletionFeb 2017
Study CompletionMar 2017
TodayJul 2026
First PostedAug 24, 2015
Enrollment StartNov 1, 2015
Primary CompletionFeb 5, 2017
Study CompletionMar 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago
Interventions
Omadacyclinedrug
Injection for IV; Oral tablets
Moxifloxacindrug
IV solution; Oral tablets