Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
Primary Purpose
Carriage of Carbapemen-resistant Klebsialle Pneumoniae
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Sponsored by
About this trial
This is an interventional trial for Carriage of Carbapemen-resistant Klebsialle Pneumoniae
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
Sites / Locations
- Soroka University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
2
1
Arm Description
Oral solution of 0.45% saline and oral solution of H2O & saccharine. Oral gel composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene
Oral solution and buccal gel of gentamicin and polymyxin E
Outcomes
Primary Outcome Measures
Eradication of CRKP carriage measured by negative rectal swabs
Secondary Outcome Measures
No new in-hospital acquisition of CRKP
Full Information
NCT ID
NCT00753558
First Posted
September 2, 2008
Last Updated
September 19, 2010
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00753558
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carriage of Carbapemen-resistant Klebsialle Pneumoniae
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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 Title
1
Arm Type
Active Comparator
Arm Description
Oral solution and buccal gel of gentamicin and polymyxin E
Intervention Type
Drug
Intervention Name(s)
Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Intervention Description
Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel.
Arm #2: Oral placebo solutions, placebo buccal gel.
Primary Outcome Measure Information:
Title
Eradication of CRKP carriage measured by negative rectal swabs
Time Frame
Two days after treatment ends
Secondary Outcome Measure Information:
Title
No new in-hospital acquisition of CRKP
Time Frame
Six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
17244516
Citation
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.
Results Reference
background
PubMed Identifier
12687326
Citation
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.
Results Reference
background
PubMed Identifier
11751791
Citation
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.
Results Reference
background
PubMed Identifier
10896796
Citation
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.
Results Reference
background
PubMed Identifier
14522530
Citation
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.
Results Reference
background
PubMed Identifier
12973164
Citation
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.
Results Reference
background
PubMed Identifier
2655521
Citation
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.
Results Reference
result
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Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
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