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

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ClinicalTrials.gov Identifier: NCT00250133
Recruitment Status : Terminated (Unable to obtain funding to complete study never started study)
First Posted : November 7, 2005
Last Update Posted : September 3, 2007
Sponsor:
Information provided by:
University of Pittsburgh

Study Description
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Brief Summary:

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 or disease Intervention/treatment
VRE Colonization Procedure: Blood draws

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Study Design
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Study Type : Observational
Enrollment : 40 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00250133     History of Changes
Other Study ID Numbers: IRB#0503005
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: September 3, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Gentamicins
Colistin
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Ionophores
Membrane Transport Modulators