30 Participants Needed

A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.

AJ
Overseen ByAlena Jandourek, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking most prescription medications, except for certain contraceptives and hormone therapies, at least 14 days before the study. Over-the-counter medications and supplements should be stopped 7 days before the study, with some exceptions for low-dose acetaminophen.

What data supports the effectiveness of the drug Metronidazole, Zidebactam-Cefepime?

Research shows that the combination of cefepime and zidebactam is effective against various Gram-negative bacterial infections, including those resistant to other antibiotics. Cefepime has been successful in treating infections caused by resistant bacteria, and when combined with zidebactam, it enhances its ability to fight tough infections.12345

Is the treatment generally safe for humans?

Cefepime, part of the treatment combination, has been tested in humans and was generally well tolerated, with only minor side effects like diarrhea reported in a few cases. The combination with zidebactam is still under clinical evaluation, but no major safety concerns have been highlighted in the available research.46789

How is the drug Metronidazole, Zidebactam-Cefepime different from other treatments?

The combination of Zidebactam and Cefepime is unique because it acts as a β-lactam/β-lactam enhancer, which helps it overcome resistance mechanisms in bacteria that are resistant to many other antibiotics. This makes it particularly effective against multidrug-resistant Gram-negative bacteria, offering a new option for infections that are difficult to treat with existing drugs.5671011

What is the purpose of this trial?

This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and receive single doses of (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h); (2) metronidazole 0.5 g IV alone administered over 1 h; and (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.

Eligibility Criteria

This trial is for healthy adult men and women who can participate in a study to test the safety of new drug combinations. Participants will receive single doses of Zidebactam-Cefepime (ZID-FEP) and Metronidazole, both alone and together, with breaks in between treatments.

Inclusion Criteria

Body mass index of 18 to 31 kg/m2 (inclusive)
Subjects voluntarily consented to participate in this study and who have signed and dated the informed consent form
Resting supine blood pressure of 90 to 139 (systolic)/50 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute
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Exclusion Criteria

I have a history of bleeding disorders.
History of Clostridium difficile induced diarrhea or infection within 1 year before screening
Consumed more than 28 units of alcohol per week at any time in the 6 months before study drug administration (1 unit of alcohol is equivalent to 8 ounces of beer, 4 ounces of wine, or 1 ounce of spirits) or history of active alcoholism and/or drug/chemical abuse within the last 3 to 5 years
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single doses of ZID-FEP and metronidazole alone or in combination over 3 treatment periods with a 48-hour washout period between each

1 week
3 visits (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

1 week
3 visits (in-person)

Treatment Details

Interventions

  • Metronidazole
  • Zidebactam-Cefepime
Trial Overview The study is testing how safe ZID-FEP combined with Metronidazole is and how these drugs behave in the body when given separately or together. It's a Phase I trial where each participant receives three different treatments across separate periods.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Zidebactam CefepimeExperimental Treatment3 Interventions
Zidebactam Cefepime 3gm Vial

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wockhardt

Lead Sponsor

Trials
36
Recruited
3,500+

Eric Solutions LLC

Collaborator

Trials
2
Recruited
50+

Findings from Research

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.
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.
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]
Cefepime demonstrated effective antibacterial activity against Enterobacter species with reduced susceptibility to other beta-lactam antibiotics, as all 17 infections in the study responded positively to treatment.
The study, involving 16 patients with various infections, showed that cefepime led to the eradication of bacteria in 88.2% of cases, with no emergence of resistance, highlighting its potential as a reliable treatment option for resistant infections.
Efficacy of cefepime in the treatment of infections due to multiply resistant Enterobacter species.Sanders, WE., Tenney, JH., Kessler, RE.[2019]

References

In vitro activity of cefepime/zidebactam (WCK 5222) against recent Gram-negative isolates collected from high resistance settings of Greek hospitals. [2021]
WCK 5222 (Cefepime-Zidebactam) Antimicrobial Activity against Clinical Isolates of Gram-Negative Bacteria Collected Worldwide in 2015. [2023]
Efficacy of cefepime in the treatment of infections due to multiply resistant Enterobacter species. [2019]
WCK 5222 (cefepime/zidebactam) antimicrobial activity tested against Gram-negative organisms producing clinically relevant β-lactamases. [2018]
[Cefepime (Maxipime) treatment efficacy in surgical patients ]. [2018]
Successful Use of Cefepime-Zidebactam (WCK 5222) as a Salvage Therapy for the Treatment of Disseminated Extensively Drug-Resistant New Delhi Metallo-β-Lactamase-Producing Pseudomonas aeruginosa Infection in an Adult Patient with Acute T-Cell Leukemia. [2023]
Evaluation of the in vitro activity of WCK 5222 (cefepime/zidebactam) and currently available combination therapies against single- and double-carbapenemase producing Enterobacteriaceae: Expanding the zone of hope. [2020]
Activity of cefepime/zidebactam (WCK 5222) against Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii endemic to New York City medical centres. [2020]
Open trial of cefepime (BMY 28142) for infections in hospitalized patients. [2021]
Cefepime: a review of its use in the management of hospitalized patients with pneumonia. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Activity of β-lactam plus β-lactam-enhancer combination cefepime/zidebactam against Klebsiella pneumoniae harbouring defective OmpK35/36 porins and carbapenemases. [2021]
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