At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 541 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 Ertapenem in Complicated Intra-abdominal Infections
In Brief
A Phase 3 clinical trial evaluating Eravacycline, Ertapenem, and 1 other intervention for Complicated Intra-abdominal Infections. Completed, enrolled 541 participants across 69 sites in 13 countries.
Detailed Summary
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra-abdominal Infections
CountriesArgentina, Bulgaria, Czechia, Estonia, France, Germany, Latvia, Lithuania, Romania, Russia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartAug 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedMay 1, 2013
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.2 years ago
Interventions
Eravacyclinedrug
Ertapenemdrug
Placebodrug
Administered IV to maintain the blind.