Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

This study has been completed.
Sponsor:
Information provided by:
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00617227
First received: February 4, 2008
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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
Clostridium Difficle Colitis
Clostridium Difficle Associated Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of Serum Vancomycin in Patients Receiving Enteral ( Oral/Intracolonic) Vancomycin.

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Patients with detectable serum vancomycin levels during enteral vancomycin therapy [ Time Frame: 5-7days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2007
Study Completion Date: February 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Clostridium difficile associated colitis on enteral vancomycin therapy

Criteria

Inclusion Criteria:

  • Patients on enteral vancomycin therapy

Exclusion Criteria:

  • Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617227

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

No publications provided

Responsible Party: Edward K.Chapnick, MD Director Division of Infectious Diseases, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00617227     History of Changes
Other Study ID Numbers: Maimid, Resident research grant
Study First Received: February 4, 2008
Last Updated: February 9, 2010
Health Authority: United States: Maimonides Medical Center Research Oversee Committee

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

Additional relevant MeSH terms:
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014