SDD for Eradicating CRKP Carriage

Soroka University Medical Center100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

100

Conditions

Carriers of Carbapenem-resistant Klebsiella Pneumonia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

SDD for Eradicating CRKP Carriage

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts