Phase 2
N=7
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT02159859 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients — 663.1 mcg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ertapenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients |
663.1 | — |
| PRIMARY Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients |
44.3 | — |
| PRIMARY Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients |
6225 | — |
| PRIMARY Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients |
19.3 | — |
| PRIMARY Mean Time to Cmax of Ertapenem in Hemodialysis Patients |
0.5 | — |
| SECONDARY Number of Participants With Diarrhea |
1 | — |
| SECONDARY Number of Participants With Nausea and Vomiting |
1 | — |
| SECONDARY Number of Participants With Headache |
— | — |
| SECONDARY Number of Participants With Injection Site Reaction |
— | — |
Summary
The purpose of this study is to determine the amount of ertapenem in the blood over time between 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
Data sourced from ClinicalTrials.gov (NCT02159859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.