Study to Assess 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

Phase 1

Conditions: Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)
MedDRA version: 20.1Level: LLTClassification code 10001032Term: Acute pyelonephritisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 21.0Level: LLTClassification code 10080628Term: Complicated urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2021-001441-12-LT

Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Male or female patients = 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 = 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;
Complete list of inclusion criteria is in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

1. Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (= 105 CFU/mL), isolated from study-qualifying urine culture;
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;
3. Has only a known Gram-positive primary uropathogen (= 105 CFU/mL), isolated from study qualifying urine culture;
Complete list of exclusion criteria is in the protocol.