Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)
Conditions
Interventions
Patients will receive either 2 g cefepime/1 g nacubactam, 2 g aztreonam/1 g nacubactam, or 1 g imipenem/1 g cilastatin every 8 hours (plus or minus 1 hour) for at least 5 days and up to 14 days. Study
OP0595, nacubactam, cUTI, AP
Sponsors
Suwada Keisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible to participate in the study: 1. 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 2. Weight at most 140 kg 3. 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
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participation in the study: 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 discretion of Investigator. 2. 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. 3. Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication. | — |
Countries
Bulgaria, China, Croatia, Czech Republic, Estonia, Georgia, Japan, Latvia, Lithuania, Slovakia
Contacts
Public ContactClinical Development Dept.
Meiji Seika Pharma Co.,Ltd.
Outcome results
None listed