FEP-ZID for Urinary Tract Infections

No longer recruiting at 124 trial locations

Overseen By Medical Monitor, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Wockhardt

Must not be taking: Beta-lactams

Disqualifiers: Seizure disorder, Renal dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FEP-ZID (cefepime-zidebactam) for serious urinary tract infections (UTIs) that require hospitalization. The researchers aim to determine if FEP-ZID is as effective as the existing antibiotic, meropenem, in treating these infections. Participants will receive either FEP-ZID or meropenem for 7 to 10 days while hospitalized. The study seeks adults who are hospitalized with complicated UTIs or a kidney infection and are experiencing symptoms like pain and frequent urination. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently on antibiotics, you may need to stop if you've been on them for more than 72 hours, unless they are not working or the bacteria is resistant.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cefepime-zidebactam (FEP-ZID) effectively treats difficult infections. One study found that five patients with hard-to-treat infections tolerated FEP-ZID well, with no major safety issues reported. This suggests FEP-ZID can be safe for humans.

Meropenem, the other treatment being compared, is an approved antibiotic with a good safety record for treating various infections, indicating it is generally well-tolerated by patients.

Both treatments in this study have demonstrated positive safety profiles, suggesting they are likely safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cefepime-zidebactam (FEP-ZID) is unique because it combines cefepime, a well-known antibiotic, with zidebactam, a novel beta-lactamase inhibitor. This pairing is designed to tackle resistant strains of bacteria that cause urinary tract infections, which are often tough to treat with standard antibiotics like ciprofloxacin and nitrofurantoin. Researchers are excited about FEP-ZID because it targets a wider array of bacteria by neutralizing their defense mechanisms, potentially leading to faster and more effective treatment outcomes.

What evidence suggests that this trial's treatments could be effective for cUTI or AP?

Studies have shown that cefepime-zidebactam (FEP-ZID), one of the treatments tested in this trial, works well against difficult bacterial infections. Research indicates that FEP-ZID effectively treats infections caused by resistant bacteria, such as certain types of E. coli. It is particularly strong against Enterobacterales, a group of bacteria often responsible for urinary tract infections. Patients with hard-to-treat infections have experienced positive results with this treatment. This suggests that FEP-ZID could be a promising option for treating complicated urinary tract infections (cUTI) and acute kidney infections (AP), especially when regular antibiotics fail. Another treatment tested in this trial is Meropenem, which serves as an active comparator. ^{2 3 6 7 8}

Who Is on the Research Team?

Ashima Bhatia, MD

Principal Investigator

Wockhardt

Manishkumar D Shah, PhD

Principal Investigator

Wockhardt

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provide a signed written informed consent prior to any study-specific procedures

Agrees to use effective methods of contraception

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

Exclusion Criteria

Pregnant or breastfeeding women

You are allergic to beta-lactam antibiotics.

You have an illness that is getting worse quickly and you may not live through the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication (FEP-ZID or meropenem) for 7 to 10 days while hospitalized

1-2 weeks

Daily visits (in-person, hospitalized)

Test-of-Cure

Assessment of microbiological eradication and clinical cure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cefepime-zidebactam (FEP-ZID)
• Meropenem

Trial Overview 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.

How Is the Trial Designed?

Group I: Cefepime-zidebactam (FEP-ZID) Experimental Treatment 1 Intervention

Group II: Meropenem Active Control 1 Intervention

Who Is Running the Clinical Trial?

Wockhardt

Lead Sponsor

Trials

36

Recruited

3,500+

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD

Published Research Related to This Trial

Cefepime combined with zidebactam (FEP-ZID) demonstrated a broad and potent in vitro activity against multidrug-resistant (MDR) bacteria, including challenging strains of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii.

FEP-ZID was effective against various carbapenemase-producing bacteria and P. aeruginosa with multiple resistance mechanisms, suggesting it could be a promising treatment option for severe infections caused by these resistant pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of Cefepime-Zidebactam against Multidrug-Resistant (MDR) Gram-Negative Pathogens. Thomson, KS., AbdelGhani, S., Snyder, JW., et al.[2020]

Cefepime/zidebactam has demonstrated significant efficacy against carbapenem-resistant Gram-negative infections, showing effective minimum inhibitory concentrations (MIC50/90) of 0.5/2 mg/L against Enterobacterales, including those producing metallo-β-lactamases, in a study of 563 isolates from Greek hospitals.

The effectiveness of cefepime/zidebactam against multi-drug-resistant bacteria is attributed to its novel β-lactam-enhancer mechanism, making it a promising treatment option where other antibiotics, like colistin, show limited activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro activity of cefepime/zidebactam (WCK 5222) against recent Gram-negative isolates collected from high resistance settings of Greek hospitals. Bhagwat, SS., Legakis, NJ., Skalidis, T., et al.[2021]

WCK 5222, a combination of cefepime and zidebactam, demonstrated strong in vitro activity against a wide range of Gram-negative bacteria, including 99.9% effectiveness against Enterobacteriaceae and significant efficacy against carbapenem-resistant strains.

The combination was particularly effective with lower minimum inhibitory concentration (MIC) values compared to cefepime alone, indicating its potential as a powerful treatment option for multidrug-resistant bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WCK 5222 (Cefepime-Zidebactam) Antimicrobial Activity against Clinical Isolates of Gram-Negative Bacteria Collected Worldwide in 2015. Sader, HS., Castanheira, M., Huband, M., et al.[2023]

Meropenem-vaborbactam is effective against complicated urinary tract infections and acute pyelonephritis caused by carbapenem-resistant Enterobacteriaceae, as shown in the Phase III trial TANGO I.

The drug is safe, well tolerated, and has better pharmacokinetic and pharmacodynamic profiles compared to other antibiotics targeting the same resistant bacteria, making it a valuable option for treating infections caused by K. pneumoniae carbapenemase-producing CRE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam: a new weapon in the war against infections due to resistant Gram-negative bacteria. Patel, TS., Pogue, JM., Mills, JP., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04979806

NCT04979806 | Study of Cefepime-zidebactam (FEP-ZID ... This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S221371652500164X

Successful use of cefepime/zidebactam in deep-seated ... All reported patients had successful outcomes. Encouraged by the findings of these studies and with a dearth of safe and effective therapeutic options, we ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10433852/

Successful Use of Cefepime/Zidebactam (WCK 5222) ... This case provides support for limited-scope use of cefepime-zidebactam for treating disseminated infections secondary to NDM-producing XDR PA.

4. jmilabs.com jmilabs.com/data/posters/2022.JAC_.Sader_.10.1093-21-WRC-02-M1.pdf

Antimicrobial activity of cefepime/zidebactam (WCK 5222), ... Cefepime/zidebactam was tested at a 1:1 ratio. Results: Cefepime/zidebactam was highly active against Enterobacterales (MIC50/90 0.03/0.25 mg/L; ...

5. academic.oup.com academic.oup.com/jac/article/78/5/1191/7078466

In vitro activity of cefepime/zidebactam and ... - Oxford Academic The aim of our study was to assess the in vitro activity of cefepime/taniborbactam and cefepime/zidebactam against such aztreonam/avibactam-resistant E. coli ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04979806?term=ZIDEBACTAM&viewType=Table&rank=5

Study of Cefepime-zidebactam (FEP-ZID) in Complicated ... This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04979806

NCT04979806 | Study of Cefepime-zidebactam (FEP-ZID ... This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem ...

8. journals.asm.org journals.asm.org/doi/10.1128/aac.01432-20

In Vitro Activity of WCK 5222 (Cefepime-Zidebactam) against ... In the current study, the combination of cefepime-zidebactam (MIC50, 8 μg/ml; MIC90, 32 μg/ml) was 2- to 4-fold more potent than cefepime alone ...