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SDD for Eradicating CRKP Carriage

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ClinicalTrials.gov Identifier: NCT01761487
Recruitment Status : Unknown
Verified October 2012 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Carriers of Carbapenem-resistant Klebsiella Pneumonia Device: Gentamicin and polymyxin E Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS
Study Start Date : January 2013
Estimated Primary Completion Date : February 2014


Arm Intervention/treatment
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



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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761487


Contacts
Contact: Lisa Saidel-Odes, MD 972-8-6400370 saidelod@bgu.ac.il

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

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01761487     History of Changes
Other Study ID Numbers: 0285-12
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: October 2012

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