Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Phase 3

Completed

• Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis
• Interventions: Drug: co-administration of aztreonam and nacubactam; Drug: imipenem/cilastatin; Drug: co-administration of cefepime and nacubactam

• Registration Number: NCT05887908
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-25
• Study Start: 2023-05-23
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Status Verified: 2024-06
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

1. 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;
2. Weight at most 140 kg;
3. 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;

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Exclusion Criteria

1. 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.
2. 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.
3. Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
co-administration of aztreonam and nacubactam	co-administration of aztreonam and nacubactam	co-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion)
imipenem/cilastatin	imipenem/cilastatin	combination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion)
co-administration of cefepime and nacubactam	co-administration of cefepime and nacubactam	co-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion)

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the proportion of patients who achieve composite clinical and microbiological success at TOC in the Microbiological Modified Intent-to-Treat (m-MITT) Population.	7 [±2] days after EOT [Day 10 to 23]	Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.

Trial Locations

Locations (1)

Meiji Research Site; 🇪🇪 Meegomäe, Voru, Estonia