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Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

NCT ID: NCT00617227

Last Updated: 2010-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Clostridium Difficle Colitis Clostridium Difficle Associated Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients on enteral vancomycin therapy

Exclusion Criteria

* Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maimonides Medical Center

Principal Investigators

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Edward K Chapnick, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

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Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Resident research grant

Identifier Type: -

Identifier Source: secondary_id

Maimid

Identifier Type: -

Identifier Source: org_study_id

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