At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 201 enrolled
Drug / intervention
Omadacycline +2 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 Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.
In Brief
A Phase 2 clinical trial evaluating Omadacycline and Levofloxacin for Acute Pyelonephritis. Completed, enrolled 201 participants across 31 sites in 4 countries.
Detailed Summary
The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pyelonephritis
CountriesGeorgia, Latvia, Russia, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartNov 2018
First PostedNov 2018
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedNov 28, 2018
Enrollment StartNov 19, 2018
Primary CompletionJun 26, 2019
Study CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.6 years ago
Interventions
Omadacyclinedrug
po tablets
Levofloxacindrug
iv solution/po tablets
Omadacyclinedrug
iv solution