Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

William Beaumont Hospitals

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Ertapenem

Study type: Interventional

Funder types: Other

Identifiers

NCT02159859

OH-D-Ertapenem-HD

Details and patient eligibility

About

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

Full description

After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.

Enrollment: 7 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Ertapenem

Experimental group

Description:

Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session

Treatment:

Drug: Ertapenem