A Phase 3 interventional study of WCK 4282 (FEP-TAZ) 4 g and Meropenem in Complicated Urinary Tract Infection and Acute Pyelonephritis, sponsored by Wockhardt. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Wockhardt · Phase 3, Interventional, and Treatment
This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 1004 hospitalized adult subjects (≥18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria
Subjects will be randomized in a 1:1 ratio according to an Interactive Response Technology (IRT) electronic system to receive either FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h) or meropenem 1 g IV q8h. FEP-TAZ will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam)
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's planned enrollment of 1,004 is above the median of 175 across 62 interventional studies indexed under Pyelonephritis.
Browse Pyelonephritis studies →Wockhardt is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
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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
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:
Exclusion Criteria:
WCK 4282 (FEP-TAZ) Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
Drug: WCK 4282 (FEP-TAZ) 4 g · Drug: ciprofloxacin 500 mg Optional Oral Switch
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
Drug: Meropenem · Drug: ciprofloxacin 500 mg Optional Oral Switch · Other: Infusion of normal saline
WCK 4282 (FEP-TAZ) 4 g \[2 g FEP and 2 g TAZ\] IV q8h, infused over 90 min
1 g IV q8h, infused over 45 min
ciprofloxacin 500 mg PO q12h
Infusion of normal saline over 45 min
Percentage of subjects with overall success at Day 5
Overall success is defined as complete resolution (or return to premorbid state) of the cUTI or AP symptoms that were present at screening, except flank pain (if present), which should show at least one grade improvement and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Time frame: Day 5
Percentage of subjects with overall success at Test-of-Cure
Overall success is defined as complete resolution1 (or return to premorbid state) of the cUTI or AP symptoms that were present at Screening and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Time frame: Test Of Cure Visit (Day 17 ± 2 days)
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Collection of number of adverse events.
Time frame: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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