4 completed. 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
Follow nacubactam: new trials by email Literature Review of nacubactam trials Research Report on nacubactam
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, BAT - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 3 | Completed | Meiji Seika Pharma Co., Ltd. | 126 | 2023-09-22 | 2026-04-13 |
| Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, imipenem/cilastatin - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 3 | Completed | Meiji Seika Pharma Co., Ltd. | 614 | 2023-05-23 | 2025-12-24 |
| A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants nacubactam, meropenem - Gram-negative Bacterial Infections | Phase 1 | Completed | Hoffmann-La Roche | 21 | 2017-06-15 | 2018-04-23 |
| A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595 OP0595, Placebo - Healthy Volunteers, Bacterial Infections | Phase 1 | Completed | Meiji Seika Pharma Co., Ltd. | 40 | 2014-05-01 | 2014-12-12 |
Bacterial Infections (1) · Gram-Negative Bacterial Infections (1)
Meiji Seika Pharma Co., Ltd. (3) · Hoffmann-La Roche (1)
China (2) · Czechia (2) · Georgia (2) · Japan (2) · Latvia (2) · Slovakia (2) · Australia (1) · Bulgaria (1) · Croatia (1) · Estonia (1) · France (1) · Greece (1) · Israel (1) · Lithuania (1) · Spain (1)
Mitsuharu Egawa (1)
PMID 32041717, PMID 42059802, PMID 42134354
2016 (1)