Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

• ClinicalTrials.gov Identifier: NCT00753558
• Recruitment Status: Completed
• First Posted: September 16, 2008
• Last Update Posted: September 21, 2010
• Sponsor: Soroka University Medical Center
• Information provided by: Soroka University Medical Center

Tracking Information

• First Submitted Date: September 2, 2008
• First Posted Date: September 16, 2008
• Last Update Posted Date: September 21, 2010
• Study Start Date: November 2008
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 14, 2008): Eradication of CRKP carriage measured by negative rectal swabs [ Time Frame: Two days after treatment ends ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00753558 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: September 14, 2008): No new in-hospital acquisition of CRKP [ Time Frame: Six weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Not Provided
• Condition: Carriage of Carbapemen-resistant Klebsialle Pneumoniae

Intervention

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.

Study Arms

• 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
  Intervention: Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
• Active Comparator: 1
  Oral solution and buccal gel of gentamicin and polymyxin E
  Intervention: Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00753558
• Other Study ID Numbers: sor475808CTIL
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Soroka University Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Soroka University Medical Center
• Verification Date: September 2010