Status:
COMPLETED
Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
Lead Sponsor:
Albany College of Pharmacy and Health Sciences
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).
Detailed Description
BACKGROUND: Infection is a leading cause of morbidity and mortality in end-stage renal disease (ESRD) patients.\[1, 2\] Ertapenem is an antibiotic used for the treatment of infections caused by sever...
Eligibility Criteria
Inclusion
- i. Inclusion criteria Adult patients (≥ 18 years), non-infected (afebrile, lack of constitutional symptoms and no leukocytosis), on a stable PD regimen (at least one month) are eligible for participation. Both patients with and without residual renal function will be studied. Non-anuric patients concurrently receiving medications with the potential to inhibit active tubular secretion will be allowed to enter the study after a 2-week washout period. These medications include H2-antagonists, trimethoprim, or probenecid. The patient and their physician at the Hortense and Louis Rubin Dialysis Center will contacted if any medication needs to be discontinued.
- ii. Exclusion criteria Patients will be ineligible for the study if they have had peritonitis within the previous 4 weeks, clinical signs or symptoms of active infection, elevated white blood cell count, or treatment with any antibiotic within the previous 2 weeks. Patients with a hemoglobin (hgb) \< 11 g/dL will be ineligible for study inclusion. Patients with stated or documented allergies to beta-lactams medications will not be eligible. Pregnant or breastfeeding women will not be eligible for inclusion. All women of child-bearing age will need to yield a serum hCG ≤ 5 mIU/mL within 2 weeks of the scheduled study day. Patients taking valproic acid will also be excluded.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00939952
Start Date
June 1 2009
End Date
May 1 2010
Last Update
February 26 2013
Active Locations (1)
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1
Hortense and Louis Rubin Dialysis Center
Clifton Park, New York, United States, 12065