Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

Soroka University Medical Center

Overview

There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.

Study Type

INTERVENTIONAL

Conditions

Carriage of Carbapemen-resistant Klebsialle Pneumoniae

Interventions

Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.DRUG

Arm #1: Oral gentamicin \& polymyxin E, gentamicin \& polymyxin E buccal gel. Arm #2: Oral placebo solutions, placebo buccal gel.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hospitalized men and women with a positive rectal swab for CRKP * Age 18 years or older Exclusion Criteria: * Age less than 18 years * Pregnant women, lactating women * A known allergy to the study drugs

Locations (1)

Soroka University Medical Center

Beersheba, Israel

Outcomes

Primary Outcomes

Eradication of CRKP carriage measured by negative rectal swabs

Time frame: Two days after treatment ends

Secondary Outcomes

No new in-hospital acquisition of CRKP

Time frame: Six weeks

Data from ClinicalTrials.gov

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