Overview

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

Status:
Withdrawn

Trial end date:
2021-05-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wockhardt

Collaborator:

Medpace Finland OY

Treatments:

Cefepime
Ciprofloxacin
Meropenem
Tazobactam
Thienamycins

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