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Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

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

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.

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

Study Design

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
Primary Completion Date : June 2010
Study Completion Date : July 2010


Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
More Information

Publications:

ClinicalTrials.gov Identifier: NCT00753558     History of Changes
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:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Gentamicins
Polymyxins
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action