Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

NCT ID: NCT03630081

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1004 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed Description

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)

Conditions

Complicated Urinary Tract Infection; Acute Pyelonephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

WCK 4282 (FEP-TAZ) 4 g

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

Group Type: EXPERIMENTAL

WCK 4282 (FEP-TAZ) 4 g

Intervention Type: DRUG

WCK 4282 (FEP-TAZ) 4 g \[2 g FEP and 2 g TAZ\] IV q8h, infused over 90 min

ciprofloxacin 500 mg Optional Oral Switch

Intervention Type: DRUG

ciprofloxacin 500 mg PO q12h

Meropenem

Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min

Group Type: ACTIVE_COMPARATOR

Meropenem

Intervention Type: DRUG

1 g IV q8h, infused over 45 min

ciprofloxacin 500 mg Optional Oral Switch

Intervention Type: DRUG

ciprofloxacin 500 mg PO q12h

Infusion of normal saline

Intervention Type: OTHER

Infusion of normal saline over 45 min

Interventions

WCK 4282 (FEP-TAZ) 4 g

WCK 4282 (FEP-TAZ) 4 g \[2 g FEP and 2 g TAZ\] IV q8h, infused over 90 min

Intervention Type: DRUG

Meropenem

1 g IV q8h, infused over 45 min

Intervention Type: DRUG

ciprofloxacin 500 mg Optional Oral Switch

ciprofloxacin 500 mg PO q12h

Intervention Type: DRUG

Infusion of normal saline

Infusion of normal saline over 45 min

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Meet the following clinical criteria for either cUTI or AP:

A. cUTI:

1. 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

2. 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manishkumar D Shah, PhD

Role: STUDY_DIRECTOR

Wockhardt

Central Contacts

Manishkumar D Shah, PhD

Role: CONTACT

Manish.Shah@wockhardt.com

91-22-26596000 ext. 6308

Mugdha A Gupta, MMS

Role: CONTACT

mgupta@wockhardt.com

91-22-26596000 ext. 6355

References

Isler B, Harris P, Stewart AG, Paterson DL. An update on cefepime and its future role in combination with novel beta-lactamase inhibitors for MDR Enterobacterales and Pseudomonas aeruginosa. J Antimicrob Chemother. 2021 Feb 11;76(3):550-560. doi: 10.1093/jac/dkaa511.

Reference Type: DERIVED

PMID: 33332545 (View on PubMed)

Other Identifiers

W-4282-301

Identifier Type: -

Identifier Source: org_study_id