Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

Not Applicable

Completed

• Conditions: Carriage of Carbapemen-resistant Klebsialle Pneumoniae

• Registration Number: NCT00753558
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-14
• Study First Posted: 2008-09-16
• Study Start: 2008-11
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-19
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication of CRKP carriage measured by negative rectal swabs	Two days after treatment ends

Secondary Outcome Measures

Name	Time	Method
No new in-hospital acquisition of CRKP	Six weeks

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel