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Trial record 3 of 3 for:    14522530 [PUBMED-IDS]

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

Tracking Information
First Submitted Date  ICMJE September 2, 2008
First Posted Date  ICMJE September 16, 2008
Last Update Posted Date September 21, 2010
Study Start Date  ICMJE November 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2008)
Eradication of CRKP carriage measured by negative rectal swabs [ Time Frame: Two days after treatment ends ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00753558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2008)
No new in-hospital acquisition of CRKP [ Time Frame: Six weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE Carriage of Carbapemen-resistant Klebsialle Pneumoniae
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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
    Intervention: Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
  • Active Comparator: 1
    Oral solution and buccal gel of gentamicin and polymyxin E
    Intervention: Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00753558
Other Study ID Numbers  ICMJE sor475808CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Soroka University Medical Center
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP