Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae - Full Text View

Purpose

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.

Condition	Intervention
Carriage of Carbapemen-resistant Klebsialle Pneumoniae	Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Colistin Colistin sulfate Gentamicin Gentamicin sulfate

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

Eradication of CRKP carriage measured by negative rectal swabs [ Time Frame: Two days after treatment ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

No new in-hospital acquisition of CRKP [ Time Frame: Six weeks ] [ Designated as safety issue: No ]

Study Start Date:	November 2008
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: 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.
Active Comparator: 1 Oral solution and buccal gel of gentamicin and polymyxin E	Drug: 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753558

Locations

Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101

Sponsors and Collaborators

Soroka University Medical Center

More Information

Publications:

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.

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.

ClinicalTrials.gov Identifier:	NCT00753558 History of Changes
Other Study ID Numbers:	sor475808CTIL
Study First Received:	September 2, 2008
Last Updated:	September 19, 2010
Health Authority:	Israel: Ethics Commission Israel: Ministry of Health

Additional relevant MeSH terms:

Pneumonia
Klebsiella Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Colistin

Gentamicins
Polymyxins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013