Clinical Trial: Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Hadassah Medical Organization

Current Primary Outcome: A negative stool culture for Carbapenem resistant Klebsiella pneumonia. [ Time Frame: 4 weeks. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: A negative stool culture and/or PCR assay for CRKP at twelve weeks after initiation of probiotics (i.e - 8 weeks after cessation of probiotic treatment). [ Time Frame: 12 weeks beginning of intervention. ]

Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: July 23, 2008
Date Started: September 2008
Date Completion: September 2010
Last Updated: July 24, 2008
Last Verified: July 2008