What side effects are associated with this type of intervention?

Common treatments for Urinary Tract Infections (UTIs) include antibiotics such as cefepime, often used in combination with other agents like zidebactam. Known side effects of cefepime include neurotoxicity, which can manifest as confusion, seizures, and encephalopathy, particularly in patients with renal impairment. Other beta-lactam antibiotics may cause allergic reactions, gastrointestinal disturbances (such as nausea, vomiting, and diarrhea), and, less commonly, hematologic issues like neutropenia. When combined with other antibiotics, the risk of nephrotoxicity can increase, especially with agents like vancomycin. It is important to monitor for these side effects and adjust treatment as necessary.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of complicated urinary tract infections (cUTIs). Notably, ceftazidime-avibactam and ceftolozane-tazobactam are combinations similar to cefepime-zidebactam, as they pair a cephalosporin with a beta-lactamase inhibitor to enhance efficacy against resistant Gram-negative bacteria. These combinations are designed to treat infections caused by multidrug-resistant organisms, providing a broader spectrum of activity and improved outcomes in patients with severe UTIs.

What other types of research exist?

Promising novel alternatives to FEP-ZID for treating UTIs in 2024 include: <ol> <li>Meropenem: A carbapenem antibiotic that has been compared to FEP-ZID in clinical trials and is effective against a broad range of bacteria.</li> <li></li> </ol> Piperacillin-Tazobactam (TZP): Shown to be a reasonable alternative to carbapenems for ESBL-producing organisms. 3. Aztreonam: Particularly useful for patients with allergies to beta-lactams and has shown efficacy in treating Pseudomonas aeruginosa infections. 4. Ceftolozane-Tazobactam: Effective against multi-drug resistant Gram-negative bacteria, including Pseudomonas aeruginosa. 5. Cefiderocol: A siderophore cephalosporin with activity against carbapenem-resistant Gram-negative bacteria.

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Beta-lactamase inhibitor

FEP-ZID for Urinary Tract Infections

Q: What is the mechanism of action of this treatment?

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.

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 below

Select...

I need to be hospitalized to treat my urinary tract or abdominal infection.

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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.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment visit (day 7 - 10 ± 1 day) for reporting.

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 more

Awards & 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

0 / 4Eligibility criteria met

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.