Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00753558
First received: September 2, 2008
Last updated: September 19, 2010
Last verified: September 2010
  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 gel of gentamicin and polymyxin E. Arm #2: Placebo.

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

Resource links provided by NLM:


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: November 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  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

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
Study First Received: September 2, 2008
Last Updated: September 19, 2010
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Additional relevant MeSH terms:
Pneumonia
Klebsiella Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Colistin
Gentamicins
Polymyxins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014