At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 500 enrolled
Drug / intervention
Eravacycline +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 Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
In Brief
A Phase 3 clinical trial evaluating Eravacycline, Meropenem, and 1 other intervention for Complicated Intra-abdominal Infections and Complicated Appendicitis. Completed, enrolled 500 participants across 54 sites in 11 countries.
Detailed Summary
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Czechia, Estonia, Georgia, Hungary, Latvia, Lithuania, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartOct 2016
Primary CompletionMay 2017
Study CompletionMay 2017
TodayJul 2026
First PostedMay 27, 2016
Enrollment StartOct 13, 2016
Primary CompletionMay 8, 2017
Study CompletionMay 19, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.1 years ago
Interventions
Eravacyclinedrug
Meropenemdrug
Placebodrug