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

NCT03630081 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: W-4282-301
• Study Type: interventional
• Target: 1,004
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complicated Urinary Tract Infection; Acute Pyelonephritis

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  Test Of Cure Visit (Day 17 ± 2 days)

• Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)

  Collection of number of adverse events.

  Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)

Study Arms (2)

WCK 4282 (FEP-TAZ) 4 g

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

WCK 4282 (FEP-TAZ) 4 g DRUG

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

WCK 4282 (FEP-TAZ) 4 g

Meropenem DRUG

1 g IV q8h, infused over 45 min

Meropenem

ciprofloxacin 500 mg Optional Oral Switch DRUG

ciprofloxacin 500 mg PO q12h

Meropenem; WCK 4282 (FEP-TAZ) 4 g

Infusion of normal saline OTHER

Infusion of normal saline over 45 min

Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Evidence of pyuria within 48 h prior to randomization,

You may not qualify if:

• 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

Sponsors & Collaborators

• Wockhardt: lead

Related Publications (1)

• 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.

  PMID: 33332545 DERIVED

MeSH Terms

Interventions

Meropenem; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Manishkumar D Shah, PhD

  Wockhardt

  STUDY DIRECTOR

Central Study Contacts

Manishkumar D Shah, PhD

CONTACT

91-22-26596000; Manish.Shah@wockhardt.com

Mugdha A Gupta, MMS

CONTACT

91-22-26596000; mgupta@wockhardt.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 14, 2018
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share