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

Wockhardt logo

Wockhardt

Status and phase

Not yet enrolling
Phase 3

Conditions

Acute Pyelonephritis
Complicated Urinary Tract Infection

Treatments

Drug: ciprofloxacin 500 mg Optional Oral Switch
Drug: Meropenem
Other: Infusion of normal saline
Drug: WCK 4282 (FEP-TAZ) 4 g

Study type

Interventional

Funder types

Industry

Identifiers

NCT03630081
W-4282-301

Details and patient eligibility

About

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.

Full 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)

Enrollment

1,004 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

  • Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
  • Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,004 participants in 2 patient groups

WCK 4282 (FEP-TAZ) 4 g
Experimental group
Description:
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
Treatment:
Drug: WCK 4282 (FEP-TAZ) 4 g
Drug: ciprofloxacin 500 mg Optional Oral Switch
Meropenem
Active Comparator group
Description:
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
Treatment:
Other: Infusion of normal saline
Drug: ciprofloxacin 500 mg Optional Oral Switch
Drug: Meropenem

Trial contacts and locations

0

Loading...

Central trial contact

Manishkumar D Shah, PhD; Mugdha A Gupta, MMS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems