At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 83 enrolled
Drug / intervention
Imipenem+Cilastatin/Relebactamdrug
Likely dose
Imipenem+Cilastatin/Relebactam 100 mgfrom 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 III Non-randomized, Non-controlled, Open Label Clinical Trial to Study the Safety and Efficacy of Imipenem/Cilastatin/Relebactam (IMI/REL [MK-7655A]) in Japanese Subjects With Complicated Intra-Abdominal Infection (cIAI) or Complicated Urinary Tract Infection (cUTI)
In Brief
A Phase 3 clinical trial evaluating Imipenem+Cilastatin/Relebactam for Complicated Intra-abdominal Infection and Complicated Urinary Tract Infection. Completed, enrolled 83 participants across 29 sites.
Detailed Summary
The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedSep 26, 2017
Enrollment StartOct 4, 2017
Primary CompletionSep 14, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.8 years ago
Interventions
Imipenem+Cilastatin/Relebactamdrug
Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours