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Beta-lactamase inhibitor
FEP-ZID for Urinary Tract Infections
Phase 3
Recruiting
Research Sponsored by Wockhardt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requires hospitalization to manage the cUTI or AP
Meet the clinical criteria for either cUTI or AP
Must not have
History of a seizure disorder requiring current treatment
Creatinine clearance < 15 mL/min or on renal dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment visit (day 7 - 10 ± 1 day)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing two antibiotics, FEP-ZID and meropenem, in hospitalized adults with serious urinary tract infections. The goal is to see which antibiotic works better. Both drugs kill bacteria by preventing them from building their cell walls. Meropenem is a well-known antibiotic effective against a variety of bacteria.
Who is the study for?
Adults (18+) hospitalized with complicated urinary tract infections or acute pyelonephritis, who agree to use contraception and can provide consent. Excluded are pregnant/breastfeeding women, those with seizure disorders, severe kidney issues, neutropenia, liver problems, extensive prior antibiotic use unless resistant infection is present.
What is being tested?
The trial compares the effectiveness of a new antibiotic combo Cefepime-zidebactam (FEP-ZID) against Meropenem in adults with serious UTIs or kidney infections. Participants will be randomly assigned treatment for 7-10 days while hospitalized.
What are the potential side effects?
Potential side effects may include allergic reactions to antibiotics like skin rashes or itching, gastrointestinal disturbances such as nausea and diarrhea, possible changes in blood tests reflecting liver or kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need to be hospitalized to treat my urinary tract or abdominal infection.
Select...
I have been diagnosed with either a complicated urinary tract infection or acute pyelonephritis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for seizures.
Select...
My kidney function is very low or I am on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment visit (day 7 - 10 ± 1 day)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment visit (day 7 - 10 ± 1 day)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Percentage of subjects with overall success at Test-of-Cure
Secondary study objectives
Percent of subjects with microbiological eradication at End-of-Treatment
Percent of subjects with microbiological eradication at Test-of-Cure
Percentage of subjects with clinical cure at End-of-Treatment
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cefepime-zidebactam (FEP-ZID)Experimental Treatment1 Intervention
Group II: MeropenemActive Control1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Urinary Tract Infections (UTIs) often involve antibiotics like cefepime and zidebactam. Cefepime, a fourth-generation cephalosporin, inhibits bacterial cell wall synthesis, causing cell death.
Zidebactam, a beta-lactamase inhibitor, protects cefepime from degradation by resistant bacteria. This combination is effective against a wide range of Gram-negative bacteria, including resistant strains.
For UTI patients, understanding these mechanisms is vital as it ensures the selection of effective antibiotic therapy, leading to successful infection eradication and resistance prevention.
Find a Location
Who is running the clinical trial?
WockhardtLead Sponsor
34 Previous Clinical Trials
2,971 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
29,349 Total Patients Enrolled
Ashima Bhatia, MDStudy DirectorWockhardt
3 Previous Clinical Trials
1,076 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to beta-lactam antibiotics.You have an illness that is getting worse quickly and you may not live through the study.I have taken antibiotics for more than 72 hours unless they didn't work or the infection was resistant.You have low levels of a type of white blood cells called neutrophils, or high liver enzyme levels.I am currently being treated for seizures.I need to be hospitalized to treat my urinary tract or abdominal infection.I have been diagnosed with either a complicated urinary tract infection or acute pyelonephritis.I am 18 years old or older.I do not have any other conditions that could affect the trial's results.My kidney function is very low or I am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Cefepime-zidebactam (FEP-ZID)
- Group 2: Meropenem
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.