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SDD for Eradicating CRKP Carriage

Information source: Soroka University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carriers of Carbapenem-resistant Klebsiella Pneumonia

Intervention: Gentamicin and polymyxin E (Device)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Soroka University Medical Center

Overall contact:
Lisa Saidel-Odes, MD, Phone: 972-8-6400370, Ext: -, Email: saidelod@bgu.ac.il

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.

Clinical Details

Official title: SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: CRKP carriage at end of treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Lisa Saidel-Odes, MD, Phone: 972-8-6400370, Ext: -, Email: saidelod@bgu.ac.il

Soroka University Medical Center, Beer Sheva, Negev 84101, Israel; Not yet recruiting
Additional Information

Starting date: January 2013
Last updated: January 3, 2013

Page last updated: August 23, 2015

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