Selective Digestive Decontamination in Carriers of Carbapenem-Resistant Klebsiella Pneumoniae
Information source: Soroka University Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carriage of Carbapemen-Resistant Klebsialle Pneumoniae
Intervention: Arm #1 :Oral solution and buccal paste of gentamicin and polymyxin E. Arm #2: Placebo. (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Soroka University Medical Center Overall contact:
Lisa Saidel-Odes, MD, Phone: 972-8-6400370, Email: saidelod@bgu.ac.il
Summary
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.
Clinical Details
Official title: 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
Study design: N/A
Primary outcome: Eradication of CRKP carriage measured by negative rectal swabs
Secondary outcome: No new in-hospital acquisition of CRKP
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lisa Saidel-Odes, MD, Phone: 972-8-6400370, Email: saidelod@bgu.ac.il
Soroka University Medical Center, Beer Sheva 84101, Israel
Additional Information
Related publications: 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. Epub 2007 Jan 22. Review. 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. Epub 2003 Apr 10. Review. Agustí C, Pujol M, Argerich MJ, Ayats J, Badía M, Domínguez 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. 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. Review. 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. 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.
Starting date: September 2008
Last updated: December 15, 2008
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