Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00617227
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : February 10, 2010
Information provided by:
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.

Condition or disease
Clostridium Difficle Colitis Clostridium Difficle Associated Disease

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of Serum Vancomycin in Patients Receiving Enteral ( Oral/Intracolonic) Vancomycin.
Study Start Date : October 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patients with detectable serum vancomycin levels during enteral vancomycin therapy [ Time Frame: 5-7days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Clostridium difficile associated colitis on enteral vancomycin therapy

Inclusion Criteria:

  • Patients on enteral vancomycin therapy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00617227

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Principal Investigator: Edward K Chapnick, MD Maimonides Medical Center

Responsible Party: Edward K.Chapnick, MD Director Division of Infectious Diseases, Maimonides Medical Center Identifier: NCT00617227     History of Changes
Other Study ID Numbers: Maimid
Resident research grant
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by Maimonides Medical Center:
Enteral vancomycin therapy, serum vancomycin levels, renal failure

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents