NCT00753558

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
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carriage of Carbapemen-resistant Klebsialle Pneumoniae

Interventions

Type	Name	Description
DRUG	Arm #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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2008-09-16
• Last updated: 2010-09-21

Locations

1 site across 1 country: Israel