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

Sponsor

Wockhardt (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03630081

Collaborator

Medpace Finland OY (Other)

Enrollment

Arms

21.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complicated Urinary Tract Infection Acute Pyelonephritis	Drug: FEP-TAZ 4 g Drug: Meropenem Drug: ciprofloxacin 500 mg Optional Oral Switch Other: Placebo infusion	Phase 3

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem Followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults

Anticipated Study Start Date :

Aug 25, 2019

Anticipated Primary Completion Date :

Aug 25, 2020

Anticipated Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FEP-TAZ 4 g FEP-TAZ Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min	Drug: FEP-TAZ 4 g 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min Drug: ciprofloxacin 500 mg Optional Oral Switch ciprofloxacin 500 mg PO q12h
Active Comparator: Meropenem Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min	Drug: Meropenem 1 g IV q8h, infused over 45 min Drug: ciprofloxacin 500 mg Optional Oral Switch ciprofloxacin 500 mg PO q12h Other: Placebo infusion Placebo infusion (normal saline) over 45 min

Arm

Intervention/Treatment

Experimental: FEP-TAZ 4 g

FEP-TAZ Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min

Drug: FEP-TAZ 4 g

4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min

Drug: ciprofloxacin 500 mg Optional Oral Switch

ciprofloxacin 500 mg PO q12h

Active Comparator: Meropenem

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

Drug: Meropenem

1 g IV q8h, infused over 45 min

Drug: ciprofloxacin 500 mg Optional Oral Switch

ciprofloxacin 500 mg PO q12h

Other: Placebo infusion

Placebo infusion (normal saline) over 45 min

Outcome Measures

Primary Outcome Measures

overall success by clinical response by improvement in clinical symptoms e.g.fever [Day 5]
overall success by microbiological eradication by laboratory culture tests e.g bacterial load [Day 5]
overall safety will be based on incidence of number of TEAEs [28 days]
overall safety will be based on incidence of number of abnormal electrocardiograms (ECGs) evaluations [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

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:

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