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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment visit (day 7 - 10 ± 1 day)
Awards & highlights
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.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Percentage of subjects with overall success at Test-of-Cure
Secondary outcome measures
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
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cefepime-zidebactam (FEP-ZID)Experimental Treatment1 Intervention
Group II: MeropenemActive Control1 Intervention
Find a Location
Who is running the clinical trial?
WockhardtLead Sponsor
34 Previous Clinical Trials
2,971 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,087 Total Patients Enrolled
Ashima Bhatia, MDStudy DirectorWockhardt
3 Previous Clinical Trials
1,076 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other completed or ongoing clinical trials that have studied FEP-ZID?
"FEP-ZID was first studied in 2016 at Rainbow Babies and Childrens Hospital. As of now, there are 89 completed studies and 16 live trials. These trials are conducted in various locations, with a notable concentration in Chula Vista, California."
Answered by AI
To what infections does Cefepime-zidebactam (FEP-ZID) lend the most help?
"Cefepime-zidebactam (FEP-ZID), often used to treat pneumonia, can also be used to manage urinary tract infection, bacterial infections, and communicable diseases."
Answered by AI
Has research like this been done before?
"Since 2016, Cefepime-zidebactam (FEP-ZID) has undergone a lot of clinical research. The first trial, which had 60 participants, was sponsored by Rempex in 2016. After the success of the first trial, Cefepime-zidebactam (FEP-ZID) received Phase 1 drug approval. As of now, there are 16 active trials happening in 42 cities and 20 countries."
Answered by AI
Who else is applying?
What site did they apply to?
Chula Vista
What portion of applicants met pre-screening criteria?
Met criteria
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