Clinical trial NCT02159859: Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Official title: Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: ertapenem
pharmacokinetic
pharmacodynamics
hemodialysis
requires hemodialysis three times a week
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2014-06-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
timeFrame: 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
measure: Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients
timeFrame: 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
measure: Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients
timeFrame: 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
measure: Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients
timeFrame: 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
measure: Mean Time to Cmax of Ertapenem in Hemodialysis Patients
timeFrame: 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 outcomes:
measure: Number of Participants With Diarrhea
timeFrame: Up to seven days after the administration of ertapenem
measure: Number of Participants With Nausea and Vomiting
timeFrame: Up to seven days after the administration of ertapenem
measure: Number of Participants With Headache
timeFrame: Up to seven days after the administration of ertapenem
measure: Number of Participants With Injection Site Reaction
timeFrame: Up to seven days after the administration of ertapenem
Other outcomes:
measure: Number of Participants With Any Adverse Events
timeFrame: Up to seven days after the administration of ertapenem
Locations:
city: Dearborn
country: United States
facility: Oakwood Hospital - Dearborn
state: Michigan
Study officials:
affiliation: Oakwood Hospital - Dearborn
name: Lama Hsaiky, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oakwood Hospital - Dearborn
name: Lama Hsaiky, Pharm.D.
role: STUDY_CHAIR
References:
citation: Hsaiky LM, Salinitri FD, Wong J, Jennings ST, Desai NH, Lobkovich AM, Cha R. Pharmacokinetics and investigation of optimal dose ertapenem in intermittent hemodialysis patients. Nephrol Dial Transplant. 2019 Oct 1;34(10):1766-1772. doi: 10.1093/ndt/gfy166.