FEP-ZID for Urinary Tract Infections

Recruiting at 108 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

530 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Cefepime-zidebactam (FEP-ZID) for treating urinary tract infections?

Research shows that Cefepime-zidebactam (FEP-ZID) is effective against a wide range of Gram-negative bacteria, including those resistant to other antibiotics. This suggests it could be a promising option for treating complicated urinary tract infections caused by these difficult-to-treat bacteria. ^{1 2 3 4 5}

Is FEP-ZID (Cefepime-zidebactam) safe for humans?

The safety of FEP-ZID specifically isn't detailed, but similar treatments like Meropenem have been shown to be generally safe and well-tolerated in humans, with no withdrawals due to side effects in studies. ^{2 6 7 8 9}

How is the drug FEP-ZID different from other treatments for urinary tract infections?

FEP-ZID (Cefepime-zidebactam) is unique because it combines cefepime with zidebactam, which enhances its ability to fight against multidrug-resistant bacteria, including those resistant to carbapenems, a class of antibiotics often used as a last resort. This combination works by binding to specific proteins in bacteria and inhibiting enzymes that usually break down antibiotics, making it effective against tough-to-treat infections. ^{1 3 10 11 12}

Research Team

Ashima Bhatia, MD

Principal Investigator

Wockhardt

Manishkumar D Shah, PhD

Principal Investigator

Wockhardt

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Single-Center Evaluation of the Pharmacokinetics of WCK 5222 (Cefepime-Zidebactam Combination) in Subjects with Renal Impairment. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Correction to: Meropenem/Vaborbactam: A Review in Complicated Urinary Tract Infections. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

In Vivo Efficacy of Meropenem with a Novel Non-β-Lactam-β-Lactamase Inhibitor, Nacubactam, against Gram-Negative Organisms Exhibiting Various Resistance Mechanisms in a Murine Complicated Urinary Tract Infection Model. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

WCK 5222 (Cefepime-Zidebactam) Antimicrobial Activity against Clinical Isolates of Gram-Negative Bacteria Collected Worldwide in 2015. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic evaluation of meropenem and vaborbactam for the treatment of urinary tract infection. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam for the treatment of complicated urinary tract infections including acute pyelonephritis. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam: a new weapon in the war against infections due to resistant Gram-negative bacteria. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

[Multicenter comparative study of meropenem vs. imipenem in the intramuscular treatment of hospital infections of the urinary tract]. [2018]

9. Spain pubmed.ncbi.nlm.nih.gov

Meropenem/vaborbactam fixed combination for the treatment of patients with complicated urinary tract infections. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Activity of Cefepime-Zidebactam against Multidrug-Resistant (MDR) Gram-Negative Pathogens. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

In Vitro Activity of WCK 5222 (Cefepime-Zidebactam) against Worldwide Collected Gram-Negative Bacilli Not Susceptible to Carbapenems. [2021]

12. United States 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. [2021]