Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Anti-Biotic Resistance Clinical Trial

Official title: Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.

Status Not yet recruiting

Clinical Trial Summary

Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will decrease the rate of GI colonization by CRKP.

Clinical Trial Description

CRKP colonization will be determined by culture and PCR of rectal swabs. The study will include 3 arms - no intervention, probiotics and mechanical bowel cleansing + probiotics. Followup examination of rectal swab samples for the presence of CRKP will be performed at 4 weeks and 12 weeks from study entry. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anti-Biotic Resistance
• Klebsiella Infections
• Klebsiella Pneumoniae
• Pneumonia

• NCT number: NCT00722410
• Study type: Interventional
• Source: Hadassah Medical Organization
• Contact: Maya Margalit, MD
• Phone: 972-50-7874561
• Email: mayam@hadassah.org.il
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2008
• Completion date: September 2010