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Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

Information source: Maimonides Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficle Colitis; Clostridium Difficle Associated Disease

Phase: N/A

Status: Completed

Sponsored by: Maimonides Medical Center

Official(s) and/or principal investigator(s):
Edward K Chapnick, MD, Principal Investigator, Affiliation: Maimonides Medical Center


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.

Clinical Details

Official title: Measurement of Serum Vancomycin in Patients Receiving Enteral ( Oral/Intracolonic) Vancomycin.

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Patients with detectable serum vancomycin levels during enteral vancomycin therapy

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients on enteral vancomycin therapy

Exclusion Criteria:

- Coadministration of intravenous vancomycin therapy,intravenousvancomycin

administration in previous10 days.

Locations and Contacts

Maimonides Medical Center, Brooklyn, New York 11219, United States
Additional Information

Starting date: October 2007
Last updated: February 9, 2010

Page last updated: August 23, 2015

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