Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamici… (NCT00250133) | Clinical Trial Compass
TerminatedNot Applicable
Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin
Stopped: Unable to obtain funding to complete study never started study
United States40 participants
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.