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Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00617227
Enrollment
100
Registered
2008-02-15
Start date
2007-10-31
Completion date
2010-02-28
Last updated
2010-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficle Associated Disease, Clostridium Difficle Colitis

Keywords

Enteral vancomycin therapy, serum vancomycin levels, renal failure

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.

Interventions

None listed

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients on enteral vancomycin therapy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Patients with detectable serum vancomycin levels during enteral vancomycin therapy5-7days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026