Health Condition 1: J189- Pneumonia, unspecified organism
Conditions
Interventions
Intervention1: CEFEPIME-ZIDEBACTAM (FEP-ZID): Dose - FEP-ZID 3 g (2 g
cefepime + 1 g Zidebactam)
Route of administration -
Intravenous Frequency - Every
eight hours Total duration - 7 to
21 days
Contr
Sponsors
Ms Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical outcome of treatment with FEP-ZID at test of cure (TOC)Timepoint: Test of Cure visit - Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate percentage of subjects with clinical cure, microbiological eradication, all-cause mortality (ACM), safety and tolerabilityTimepoint: Visit day 14 Visit Day 28 End of treatment - Between Day 7 to Day 21 Test of cure-Day 28 Follow up- Day 35 | — |
Countries
India
Contacts
Public ContactDr Sachin Bhagwat
Wockhardt Research Centre
Outcome results
None listed