CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 614 enrolled
Drug / intervention
co-administration of cefepime and nacubactam +2 moredrug
Likely dose
co-administration of cefepime and nacubactam 2 gfrom 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.

Search/NCT05887908
NCT05887908Phase 3Completed
CompareCT.gov

A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults

Meiji Seika Pharma Co., Ltd.·interventional·Posted Jun 5, 2023·Updated Dec 24, 2025

In Brief

A Phase 3 clinical trial evaluating co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, and 1 other intervention for Complicated Urinary Tract Infection and 3 related conditions. Completed, enrolled 614 participants across 61 sites in 9 countries.

Detailed Summary

Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
CountriesBulgaria, China, Czechia, Estonia, Georgia, Japan, Latvia, Lithuania, Slovakia
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedJun 5, 2023
Enrollment StartMay 23, 2023
Primary CompletionNov 22, 2024
Study CompletionNov 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.1 years ago

Interventions

co-administration of cefepime and nacubactamdrug

2 g cefepime and 1 g nacubactam

co-administration of aztreonam and nacubactamdrug

2 g aztreonama and 1 g nacubactam

imipenem/cilastatindrug

1 g imipenem/1 g cilastatin