Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin
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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 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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Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | David L Paterson, MD | University of Pittsburgh |
More Information
| ClinicalTrials.gov Identifier: | NCT00250133 History of Changes |
| Other Study ID Numbers: |
IRB#0503005 |
| First Submitted: | November 4, 2005 |
| First Posted: | November 7, 2005 |
| 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 |