Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

A Randomized,Double-Blind,Placebo-Controled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella Pneumoniae Carriage

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753558

Enrollment

Unknown

Registered

2008-09-16

Start date

2008-11-30

Completion date

2010-07-31

Last updated

2010-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carriage of Carbapemen-resistant Klebsialle Pneumoniae

Brief summary

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.

Interventions

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

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Eradication of CRKP carriage measured by negative rectal swabs	Two days after treatment ends

Secondary

Measure	Time frame
No new in-hospital acquisition of CRKP	Six weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026