Phase 3
N=614
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Complicated Urinary Tract Infection · Acute Pyelonephritis · cUTI · AP
Bottom Line
View on ClinicalTrials.gov: NCT05887908 ↗Enrolled (actual)
614
Serious AEs
2.5%
Results posted
Nov 2025
Primary outcome: Primary: Proportion of Patients Who Achieve Composite Clinical and Microbiological Success at TOC (Test of Cure Visit) in the Microbiological Modified Intent-to-Treat (m-MITT) Population — 176; 81; 64 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- co-administration of cefepime and nacubactam (Drug); co-administration of aztreonam and nacubactam (Drug); imipenem/cilastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Achieve Composite Clinical and Microbiological Success at TOC (Test of Cure Visit) in the Microbiological Modified Intent-to-Treat (m-MITT) Population |
176; 81; 64 | — |
| SECONDARY Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome |
201; 110; 96; 199; 102; 94 | — |
| SECONDARY Proportion of Patients With a Clinical Outcome of Cure |
9; 4; 2; 204; 106; 100 | — |
| SECONDARY Proportion of Patients With a Microbiological Outcome of Eradication |
205; 112; 97; 203; 105; 95 | — |
| SECONDARY Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline |
12; 8; 6 | — |
| SECONDARY Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline |
12; 8; 6 | — |
| SECONDARY Proportion of Patients Who Are Free From the Definition of Secondary Bacteremia AND a Clinical Outcome of Cure AND a Microbiological Outcome of Eradication From cUTI or AP at TOC in Patients With Secondary Bacteremia at Baseline |
11; 4; 2 | — |
| SECONDARY Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC |
12; 8; 6 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period;
- Weight at most 140 kg;
- Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics;
Exclusion Criteria
- Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion.
- Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the Investigator's discretion.
- Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;
Data sourced from ClinicalTrials.gov (NCT05887908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.