Cefepime-zidebactam (FEP-ZID) for Urinary Tract Infection (UTI)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Urinary Tract Infection (UTI)+1 MoreCefepime-zidebactam (FEP-ZID) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug (FEP-ZID) to see if it is as effective as another drug (meropenem) in treating adults with cUTI or AP. 528 adults with cUTI or AP will be enrolled and remain hospitalized during treatment, which will last 7-10 days.

Eligible Conditions
  • Urinary Tract Infection (UTI)
  • Acute Pyelonephritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: On Days 1 and 3 of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion

Day 2
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Day 17
Percent of subjects with microbiological eradication at Test-of-Cure
Percentage of subjects with clinical cure at Test-of-Cure
Day 26
Percentage of subjects with clinical cure at Late Follow-up
Day 7
Percent of subjects with microbiological eradication at End-of-Treatment
Percentage of subjects with clinical cure at End-of-Treatment
Percentage of subjects with overall success at End-of-Treatment
Day 1
Plasma Concentration of FEP-ZID
Day 17
Percentage of subjects with overall success at Test-of-Cure

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Meropenem
1 of 2
Cefepime-zidebactam (FEP-ZID)
1 of 2

Active Control

Experimental Treatment

528 Total Participants · 2 Treatment Groups

Primary Treatment: Cefepime-zidebactam (FEP-ZID) · No Placebo Group · Phase 3

Cefepime-zidebactam (FEP-ZID)
Drug
Experimental Group · 1 Intervention: Cefepime-zidebactam (FEP-ZID) · Intervention Types: Drug
Meropenem
Drug
ActiveComparator Group · 1 Intervention: Meropenem · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: on days 1 and 3 of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion

Who is running the clinical trial?

WockhardtLead Sponsor
34 Previous Clinical Trials
2,971 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
88 Previous Clinical Trials
28,003 Total Patients Enrolled
Ashima Bhatia, MDStudy DirectorWockhardt
3 Previous Clinical Trials
1,076 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female or male, respectively, and you are 18 years of age or older.
You provide a written informed consent prior to any study-specific procedures.
You have a urinary tract infection (UTI) or acute pyelonephritis (AP) that requires hospitalization.