A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and pharmacokinetics after treatment
Treatment Details
Interventions
- Metronidazole
- Zidebactam-Cefepime
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wockhardt
Lead Sponsor
Eric Solutions LLC
Collaborator