Trials / Completed
CompletedNCT05887908
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 614 (actual)
- Sponsor
- Meiji Seika Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | co-administration of cefepime and nacubactam | 2 g cefepime and 1 g nacubactam |
| DRUG | co-administration of aztreonam and nacubactam | 2 g aztreonama and 1 g nacubactam |
| DRUG | imipenem/cilastatin | 1 g imipenem/1 g cilastatin |
Timeline
- Start date
- 2023-05-23
- Primary completion
- 2024-11-22
- Completion
- 2024-11-26
- First posted
- 2023-06-05
- Last updated
- 2025-12-24
- Results posted
- 2025-11-25
Locations
61 sites across 9 countries: Bulgaria, China, Czechia, Estonia, Georgia, Japan, Latvia, Lithuania, Slovakia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05887908. Inclusion in this directory is not an endorsement.