Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT02159859
Eligibility Criteria:
Inclusion Criteria:
* Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015
* Diagnosed with end stage renal disease and requires hemodialysis three times a week
* No allergy to β lactam medications
* Existing IV access for parenteral ertapenem infusion
* Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post.
* No evidence of hepatic disease
* No history of alcoholism or drug abuse within pervious 2 years
* Not pregnant
Exclusion Criteria:
* History of any form of epilepsy, seizure or convulsion
* Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states
* Currently taking probenecid
* Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study
* Currently receiving any antimicrobial agents for prophylaxis or treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT02159859
Study Brief:
Protocol Section:
NCT02159859