Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia - Full Text View

Sponsor:	Hadassah Medical Organization
Collaborator:	Tel Aviv University
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00722410

Purpose

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.

Condition	Intervention	Phase
Anti-Biotic Resistance Klebsiella Pneumoniae	Dietary Supplement: VSL#3 Drug: Polyethylene glycol	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ethanol, 2,2'-(oxybis(2,1-ethanediyloxy)bis- Lenapenem

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

A negative stool culture for Carbapenem resistant Klebsiella pneumonia. [ Time Frame: 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: A
Experimental: B VSL#3 for 4 weeks	Dietary Supplement: VSL#3 A probiotic preparation. Other Name: VSL#3
Experimental: C Mechanical bowel cleansing followed by VSL#3 for 4 weeks.	Dietary Supplement: VSL#3 A probiotic preparation. Other Name: VSL#3 Drug: Polyethylene glycol Oral ingestion of 3 liters of polyethylene glycol solution. Other Names: New Meroken. Precolonoscopy solution.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who are > 18 years of age.
Signing of informed consent by subject or legal custodian.
Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
Negative cultures for CRKP from extra-intestinal sites excluding urine.

Exclusion Criteria:

Subjects who have participated in another clinical trial within the last three months.
Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
Subjects who are pregnant or breast feeding.
Subjects who will be unavailable for the duration of the trial, are likely to be non-compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
Subjects with chronic diarrhea (>4 weeks).
Subjects with inflammatory bowel disease.
Subjects whose stool is positive for Clostridium difficile toxin.
Subjects receiving immunosuppressive treatment (i.e. corticosteroids; azathioprine or 6-MP; cyclosporine; tacrolimus; OKT3, methotrexate; anti TNF agents; chemotherapy).
Subjects who underwent solid organ or hematopoietic stem cell transplantation.
Subjects with primary or secondary immunodeficiency disorders, including HIV.
Subjects with chronic advanced cardiac, respiratory, renal or liver disease.
Subjects with advanced malignant disease.
Subjects with severe acute organ failure.
Subjects in whom CRKP is isolated from sites other than stool or urine (i.e. blood, sputum or wound cultures).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722410

Contacts

Contact: Maya Margalit, MD	972-50-7874561	mayam@hadassah.org.il
Contact: Hadas Lamberg, PhD	00 972 2 6777572	lhadas@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lamberg, PhD : 00 972 2 6777572 lhadas@hadassah.org.il
Sub-Investigator: Reut Zaguri, MD

Sponsors and Collaborators

Hadassah Medical Organization

Tel Aviv University

Investigators

Principal Investigator:

Maya Margalit, MD

Hadassah Medical Organization

More Information

Publications:

Leavitt A, Navon-Venezia S, Chmelnitsky I, Schwaber MJ, Carmeli Y. Emergence of KPC-2 and KPC-3 in carbapenem-resistant Klebsiella pneumoniae strains in an Israeli hospital. Antimicrob Agents Chemother. 2007 Aug;51(8):3026-9. Epub 2007 Jun 11.

Manley KJ, Fraenkel MB, Mayall BC, Power DA. Probiotic treatment of vancomycin-resistant enterococci: a randomised controlled trial. Med J Aust. 2007 May 7;186(9):454-7.

Responsible Party:	Maya Margalit, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00722410 History of Changes
Other Study ID Numbers:	CRKP-HMO-CTIL
Study First Received:	July 23, 2008
Last Updated:	July 24, 2008
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

Carbapenem
resistant
Klebsiella pneumoniae

Carpapenemases
Probiotics
VSL3

Additional relevant MeSH terms:

Pneumonia
Klebsiella Infections
Lung Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 12, 2012