SDD for Eradicating CRKP Carriage

Phase 4

• Conditions: Carriers of Carbapenem-resistant Klebsiella Pneumonia
• Interventions: Device: Gentamicin and polymyxin E

• Registration Number: NCT01761487
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04
• Primary Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm only - Gentamicin and polymyxin E	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

Primary Outcome Measures

Name	Time	Method
CRKP carriage at end of treatment	one year

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Negev, Israel