Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
NCT ID: NCT00753558
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2008-11-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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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 solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Arm #1: Oral gentamicin \& polymyxin E, gentamicin \& polymyxin E buccal gel.
Arm #2: Oral placebo solutions, placebo buccal gel.
1
Oral solution and buccal gel of gentamicin and polymyxin E
Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Arm #1: Oral gentamicin \& polymyxin E, gentamicin \& polymyxin E buccal gel.
Arm #2: Oral placebo solutions, placebo buccal gel.
Interventions
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Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Arm #1: Oral gentamicin \& polymyxin E, gentamicin \& polymyxin E buccal gel.
Arm #2: Oral placebo solutions, placebo buccal gel.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
Exclusion Criteria
* Pregnant women, lactating women
* A known allergy to the study drugs
18 Years
ALL
No
Sponsors
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Soroka University Medical Center
OTHER
Locations
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Soroka University Medical Center
Beersheba, , Israel
Countries
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References
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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.
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.
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.
Other Identifiers
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sor475808CTIL
Identifier Type: -
Identifier Source: org_study_id