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Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin

This study has been terminated.
(Unable to obtain funding to complete study never started study)
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00250133
First received: November 4, 2005
Last updated: August 31, 2007
Last verified: August 2007
History of Changes
  Purpose

Selective decontamination of the digestive tract (SDD) is a prophylactic measure aimed at reducing Gram negative flora in the gut with an aim to reduce nosocomial infections such as ventilator-associated pneumonia. A recent large randomized trial in the Netherlands showed that SDD use was associated with reduced mortality in the ICU. Theoretically, SDD may select for Gram positive organisms such as MRSA or VRE. This was not observed in the Dutch study, but the rates of MRSA and VRE are very low in hospitals in the Netherlands. Fears of selection of MRSA and VRE have limited application of SDD in the United States.

In this pilot study, 40 patients in the transplant intensive care unit (where SDD has been used intermittently for at least 10 years), will be randomized to SDD or no SDD. These patients will be known to be VRE positive at baseline. The effects of SDD on the density of VRE in the stool on day 7 compared to pre-SDD will be the primary endpoint. Secondary endpoints will be detection of MRSA and colistin resistant Pseudomonas in the stool.


Condition Intervention Phase
VRE Colonization
 Procedure: Blood draws
 Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:
Estimated Enrollment: 40
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in ICU who are identified as having VRE colonization by Infection Control's surveillance swabs or by the presence of VRE in clinical specimens.
  • Patients must be above >18 years of age.
  • Patients in whom there is an expectation of at least 4 days of mechanical ventilation.
  • Presence of a nasogastric or enteral feeding tube.
  • Written informed consent from patient or a proxy.

Exclusion criteria:

  • Allergy to colistin, gentamicin or nystatin.
  • Pregnancy.
  • Intestinal transplant or multivisceral transplant.
  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: NCT00250133

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David L Paterson, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250133     History of Changes
Other Study ID Numbers: IRB#0503005
Study First Received: November 4, 2005
Last Updated: August 31, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
selective decontamination of the digestive tract

ClinicalTrials.gov processed this record on February 26, 2015