Clinical Trial of Cefepime-Zidebactam in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
Phase 3
- Conditions
- Health Condition 1: N390- Urinary tract infection, site notspecified
- Registration Number
- CTRI/2023/06/053535
- Lead Sponsor
- Wockhardt Bio AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Male and female greater than or equal to 18 years of age. Provide a signed written informed consent prior to any study specific procedures. Meet the clinical criteria for either Complicated Urinary tract infection or Acute pyelonephritis. All females must have a negative Urine or Serum Pregnancy Test.
Exclusion Criteria
Known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy. Receipt of potentially-effective systemic antibacterial therapy within 48 hours prior to randomization. Rapidly progressive or terminal illness with a high risk of mortality due to any cause. Pregnant or breastfeeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that Cefepime-Zidebactam (FEP-ZID) is non-inferior to Meropenem in percentage of subjects with overall success at test of cure visit. To assess percentage of subjects with treatment-emergent adverse event (TEAE)Timepoint: Test of cure visit- Day 17
- Secondary Outcome Measures
Name Time Method To evaluate percentage of subjects with clinical cure, microbiological eradication with overall success at various defined visitsTimepoint: End of Treatment visit- 7 to 10 days <br/ ><br>Follow Up Visit- 26 Days