Trials / Completed
CompletedNCT05905055
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection Due to Carbapenem Resistant Enterobacterales
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Meiji Seika Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the treatment of patients with cUTI, AP, HABP, VABP, and cIAI, due to Carbapenem Resistant Enterobacterales.
Conditions
- Complicated Urinary Tract Infection
- Acute Pyelonephritis
- Hospital-acquired Bacterial Pneumonia
- Ventilator-associated Bacterial Pneumonia
- Complicated Intra-abdominal Infection
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | co-administration of cefepime and nacubactam | 2 g cefepime and 1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes |
| DRUG | co-administration of aztreonam and nacubactam | 2 g aztreonam and 1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes |
| DRUG | BAT | Dosage of BAT will be based per site's standard of care |
Timeline
- Start date
- 2023-09-22
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2023-06-15
- Last updated
- 2026-04-13
Locations
54 sites across 14 countries: China, Croatia, Czechia, France, Georgia, Greece, Israel, Japan, Latvia, Slovakia, Spain, Taiwan, Thailand, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05905055. Inclusion in this directory is not an endorsement.