SDD for Eradicating CRKP Carriage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01761487
First received: January 3, 2013
Last updated: NA
Last verified: October 2012
History: No changes posted

January 3, 2013
January 3, 2013
January 2013
February 2014   (final data collection date for primary outcome measure)
CRKP carriage at end of treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
SDD for Eradicating CRKP Carriage
SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS

There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).

In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.

The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Carriers of Carbapenem-resistant Klebsiella Pneumonia
Device: Gentamicin and polymyxin E
One arm only - Gentamicin and polymyxin E
All subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions
Intervention: Device: Gentamicin and polymyxin E
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Not Provided
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study
  • Hospitalized men or women at least 18 years of age
  • Rectal swab culture positive for CRKP in the last week
  • Will be willing to initiate and remain on treatment, except for adverse events occurring

Exclusion Criteria:

  • Age less than 18 years.
  • Pregnant women, lactating women.
  • A know allergy to one of the study drugs.
  • Renal failure with creatinine clearance less than 50mL/min.
  • Current Treatment with IV gentamicin and/or IV polymyxin E
  • Any safety, behavioral, clinical, or administrative reasons that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Both
18 Years and older
No
Contact: Lisa Saidel-Odes, MD 972-8-6400370 ext - saidelod@bgu.ac.il
Israel
 
NCT01761487
0285-12
Not Provided
Soroka University Medical Center
Soroka University Medical Center
Not Provided
Not Provided
Soroka University Medical Center
October 2012

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