Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Phase 2

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Ertapenem

Registration Number: NCT02159859

Lead Sponsor: William Beaumont Hospitals

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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ertapenem	Ertapenem	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

Primary Outcome Measures

Name	Time	Method
Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients	once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session	Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients	once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session	Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients	once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session	Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients	once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session	Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Time to Cmax of Ertapenem in Hemodialysis Patients	once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session	Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Diarrhea	Up to seven days after the administration of ertapenem	Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Number of Participants With Nausea and Vomiting	Up to seven days after the administration of ertapenem	Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Number of Participants With Headache	Up to seven days after the administration of ertapenem	Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Number of Participants With Injection Site Reaction	Up to seven days after the administration of ertapenem	Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital