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Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00753558
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
Soroka University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carriage of Carbapemen-resistant Klebsialle Pneumoniae Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Eradication of CRKP carriage measured by negative rectal swabs [ Time Frame: Two days after treatment ends ]

Secondary Outcome Measures :
  1. No new in-hospital acquisition of CRKP [ Time Frame: Six weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753558


Locations
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Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
More Information
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Publications of Results:

Other Publications:

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ClinicalTrials.gov Identifier: NCT00753558    
Other Study ID Numbers: sor475808CTIL
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Gentamicins
Polymyxins
 Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action