Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

Completed

• Conditions: Clostridium Difficle Colitis; Clostridium Difficle Associated Disease

• Registration Number: NCT00617227
• Lead Sponsor: Maimonides Medical Center

Brief Summary

The study is based on the hypothesis that decreased creatinine clearance may be associated with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas) vancomyicn for CDAD.

The objective of the study is to see whether enteral vancomycin is absorbed through the inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum concentration.

Detailed Description

Vancomycin is a large glycopeptide compound with a molecular weight of about 1450 Da. It is not appreciably absorbed orally and is eliminated primarily via the renal route. Enteral vancomycin therapy (oral/intracolonic ) is used inpatients with severe Clostridium difficile associated colitis who are unable to take oral metronidazole or have failed treatment with metronidazole. Oral vancomycin is not detectable in serum of normal persons, but concentrations below therapeutic range may be found in patients with colitis. There are a few case reports of serum concentrations within the therapeutic range after oral/intracolonic administration of vancomycin, in association with renal failure. The use of enteral vancomycin in our geriatric population with variable creatinine clearance prompted us to measure the serum vancomycin levels in these patients.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Primary Completion: 2008-05
• Status Verified: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-09
• Last Update Posted: 2010-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients on enteral vancomycin therapy

Exclusion Criteria

• Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients with detectable serum vancomycin levels during enteral vancomycin therapy	5-7days

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States