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 (Integral-1)

Meiji Seika Pharma Co.,Ltd.0 sites600 target enrollmentStarted: May 23, 2023Last updated: November 6, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: Meiji Seika Pharma Co.,Ltd.
Enrollment: 600
Primary Endpoint: proportion of patients who achieve composite clinical and microbiological success at TOC

No summary available.

•Patients who meet all of the following criteria will be eligible to participate in the study:
•Male or female patients at least 18 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 cUTI or AP of patient will require treatment with at least 5 days of IV antibiotics

•Patients who meet any of the following criteria will be excluded from participation in the study:
•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 discretion of Investigator.
•Has known or suspected single or concurrent infection with Acinetobacter species 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 discretion of Investigator.
•Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;

proportion of patients who achieve composite clinical and microbiological success at TOC

Time Frame: TOC

Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.

No secondary outcomes reported

Sponsor