NCT00250133

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

September 3, 2007

Status Verified

August 1, 2007

First QC Date

November 4, 2005

Last Update Submit

August 31, 2007

Conditions

VRE Colonization

Keywords

selective decontamination of the digestive tract

Interventions

Blood drawsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • David L Paterson, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Last Updated

September 3, 2007

Record last verified: 2007-08

Locations

US(1)