Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albany College of Pharmacy and Health Sciences
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ertapenem

Criteria

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.