Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oakwood Hospital and Medical Center; William Beaumont Hospitals
• Collaborator: Wayne State University
• Treatments: Ertapenem

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