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

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00753558

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 paste of gentamicin and polymyxin E. Arm #2: Placebo.

MedlinePlus related topics: Pneumonia

Drug Information available for: Colistin Colistin sulfate Gentamicins

U.S. FDA Resources

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

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:	September 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Oral solution of 0.45% saline and oral solution of H2O & saccharine. Oral paste composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene	Drug: Arm #1 :Oral solution and buccal paste of gentamicin and polymyxin E. Arm #2: Placebo. Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal paste. Arm #2: Oral placebo solutions,placebo buccal paste.
1: Active Comparator Oral solution and buccal paste of gentamicin and polymyxin E	Drug: Arm #1 :Oral solution and buccal paste of gentamicin and polymyxin E. Arm #2: Placebo. Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal paste. Arm #2: Oral placebo solutions,placebo buccal paste.

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

Contacts

Contact: Lisa Saidel-Odes, MD	972-8-6400370	saidelod@bgu.ac.il
Contact: Abraham Borer, MD	972-8-6403888	borer07@nir.org.il

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.

Study ID Numbers:	sor475808CTIL
Study First Received:	September 2, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00753558 History of Changes
Health Authority:	Israel: Ethics Commission; Israel: Ministry of Health

Study placed in the following topic categories:

Bacterial Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Colistin
Klebsiella
Anti-Bacterial Agents
Polymyxins

Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Gentamicins
Klebsiella Infections
Pneumonia

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Enterobacteriaceae Infections
Enzyme Inhibitors
Pharmacologic Actions
Gram-Negative Bacterial Infections
Colistin
Protein Synthesis Inhibitors

Anti-Bacterial Agents
Polymyxins
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Gentamicins
Klebsiella Infections
Pneumonia

ClinicalTrials.gov processed this record on May 07, 2009