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SDD for Eradicating CRKP Carriage

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Soroka University Medical Center Identifier:
First received: January 3, 2013
Last updated: NA
Last verified: October 2012
History: No changes posted

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.

Condition Intervention Phase
Carriers of Carbapenem-resistant Klebsiella Pneumonia Device: Gentamicin and polymyxin E Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)

Resource links provided by NLM:

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • CRKP carriage at end of treatment [ Time Frame: one year ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Gentamicin and polymyxin E


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01761487

Contact: Lisa Saidel-Odes, MD 972-8-6400370

Soroka University Medical Center Not yet recruiting
Beer Sheva, Negev, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
  More Information

Responsible Party: Soroka University Medical Center Identifier: NCT01761487     History of Changes
Other Study ID Numbers: 0285-12
Study First Received: January 3, 2013
Last Updated: January 3, 2013

Additional relevant MeSH terms:
Klebsiella Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 21, 2017