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Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

Maimonides Medical Center logo

Maimonides Medical Center

Status

Completed

Conditions

Clostridium Difficle Associated Disease
Clostridium Difficle Colitis

Study type

Observational

Funder types

Other

Identifiers

NCT00617227
Maimid
Resident research grant

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients on enteral vancomycin therapy

Exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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