Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: cefepime-tazobactam (FEP-TAZ): Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min for a max of 10 days
Control Intervention1: Meropenem IV: Dosage: 1 g IV q8h, infused over 4
Sponsors
Wockhardt Bio AG
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provide a signed written informed consent prior to any study-specific procedures 2.Meet the following clinical criteria for either cUTI or AP: A. cUTI: Have at least TWO of the following new-onset or worsening symptoms or signs: Fever (oral, tympanic, or rectal temperature >38°C [ >100.4°F]), which must be observed and documented by a health care provider Nausea or vomiting Dysuria, increased urinary frequency, or urinary urgency Lower abdominal, suprapubic, or pelvic pain Have at least ONE complicating factor B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs: 3. Evidence of pyuria within 48 h prior to randomization
Exclusion criteria
Exclusion criteria: 1.Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy. 2.Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization 3.Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that cefepime-tazobactam (FEP-TAZ) is non-inferior to meropenem in overall success (clinical response plus microbiological eradication)Timepoint: Day 5 and TOC | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate by-pathogen clinical outcomesTimepoint: Day 5 and TOC;To evaluate clinical outcomeTimepoint: Day 5;To evaluate microbiological outcomeTimepoint: Day 5 , EOIV and EOT , and TOC;To evaluate overall outcomeTimepoint: Day 5 and TOC;To evaluate sustained overall success sustained clinical cure, and sustained microbiological eradicationTimepoint: Late Follow-Up (LFU) visit | — |
Countries
Armenia, Belarus, Bulgaria, Czech Republic, Estonia, India, Latvia, Lebanon, Lithuania, Mexico, Peru, Poland, Romania, Sri Lanka, Taiwan, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Ashima Bhatia
Wockhardt Limited
Outcome results
None listed