Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
September 19, 2010 updated by: Soroka University Medical Center
A Randomized,Double-Blind,Placebo-Controled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella Pneumoniae Carriage
There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP).
The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration.
This will reduce infections and hopefully mortality caused by CRKP.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beer Sheva, Israel, 84101
- Soroka University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hospitalized men and women with a positive rectal swab for CRKP
- Age 18 years or older
Exclusion Criteria:
- Age less than 18 years
- Pregnant women, lactating women
- A known allergy to the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 2
Oral solution of 0.45% saline and oral solution of H2O & saccharine.
Oral gel composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene
|
Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel. Arm #2: Oral placebo solutions, placebo buccal gel. |
|
Active Comparator: 1
Oral solution and buccal gel of gentamicin and polymyxin E
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Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel. Arm #2: Oral placebo solutions, placebo buccal gel. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eradication of CRKP carriage measured by negative rectal swabs
Time Frame: Two days after treatment ends
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Two days after treatment ends
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
No new in-hospital acquisition of CRKP
Time Frame: Six weeks
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Six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- de Jonge E, Schultz MJ, Spanjaard L, Bossuyt PM, Vroom MB, Dankert J, Kesecioglu J. Effects of selective decontamination of digestive tract on mortality and acquisition of resistant bacteria in intensive care: a randomised controlled trial. Lancet. 2003 Sep 27;362(9389):1011-6. doi: 10.1016/S0140-6736(03)14409-1.
- Silvestri L, van Saene HK, Milanese M, Gregori D, Gullo A. Selective decontamination of the digestive tract reduces bacterial bloodstream infection and mortality in critically ill patients. Systematic review of randomized, controlled trials. J Hosp Infect. 2007 Mar;65(3):187-203. doi: 10.1016/j.jhin.2006.10.014. Epub 2007 Jan 22.
- van Saene HK, Petros AJ, Ramsay G, Baxby D. All great truths are iconoclastic: selective decontamination of the digestive tract moves from heresy to level 1 truth. Intensive Care Med. 2003 May;29(5):677-90. doi: 10.1007/s00134-003-1722-2. Epub 2003 Apr 10.
- Agusti C, Pujol M, Argerich MJ, Ayats J, Badia M, Dominguez MA, Corbella X, Ariza J. Short-term effect of the application of selective decontamination of the digestive tract on different body site reservoir ICU patients colonized by multi-resistant Acinetobacter baumannii. J Antimicrob Chemother. 2002 Jan;49(1):205-8. doi: 10.1093/jac/49.1.205.
- Silvestri L, Mannucci F, van Saene HK. Selective decontamination of the digestive tract: a life saver. J Hosp Infect. 2000 Jul;45(3):185-90. doi: 10.1053/jhin.2000.0737.
- Leone M, Albanese J, Antonini F, Nguyen-Michel A, Martin C. Long-term (6-year) effect of selective digestive decontamination on antimicrobial resistance in intensive care, multiple-trauma patients. Crit Care Med. 2003 Aug;31(8):2090-5. doi: 10.1097/01.CCM.0000079606.16776.C5.
- Brun-Buisson C, Legrand P, Rauss A, Richard C, Montravers F, Besbes M, Meakins JL, Soussy CJ, Lemaire F. Intestinal decontamination for control of nosocomial multiresistant gram-negative bacilli. Study of an outbreak in an intensive care unit. Ann Intern Med. 1989 Jun 1;110(11):873-81. doi: 10.7326/0003-4819-110-11-873.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
September 2, 2008
First Submitted That Met QC Criteria
September 14, 2008
First Posted (Estimate)
September 16, 2008
Study Record Updates
Last Update Posted (Estimate)
September 21, 2010
Last Update Submitted That Met QC Criteria
September 19, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sor475808CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.