Clinical Trial of Cefepime-Zidebactam (FEP-ZID) for the Treatment of Adult Subjects with Serious bacterial Infections
- Conditions
- Health Condition 1: J189- Pneumonia, unspecified organism
- Registration Number
- CTRI/2024/04/065043
- Lead Sponsor
- Ms Wockhardt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Male and female of 18 to 75 years of age.
Provide a signed written informed consent prior to any study specific procedures.
Meet the clinical criteria for Following infections caused by documented Carbapenem-Resistant Gram-negative Bacteria
- Hospital-acquired Bacterial Pneumonia (HABP)/Ventilator-associated Bacterial
Pneumonia (VABP) ± concurrent Bloodstream Infection (ccBSI) or
- Complicated Intra-abdominal Infection (cIAI) ± ccBSI or
- Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ± ccBSI
All females must have a negative Urine or Serum Pregnancy Test.
Subjects with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
Receipt of potentially-effective systemic antibacterial therapy with potential activity
against carbapenem-resistant Gram-negative bacteria within 48 hours during the 72 hours prior to treatment initiation.
Pregnant or breastfeeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the clinical outcome of treatment with FEP-ZID at test of cure (TOC)Timepoint: Test of Cure visit - Day 28
- Secondary Outcome Measures
Name Time Method To evaluate percentage of subjects with clinical <br/ ><br>cure, microbiological eradication, all-cause mortality (ACM), safety and tolerabilityTimepoint: Visit day 14 <br/ ><br>Visit Day 28 <br/ ><br>End of treatment - Between Day 7 to Day 21 <br/ ><br>Test of cure-Day 28 <br/ ><br>Follow up- Day 35