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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014