Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia
NCT ID: NCT00722410
Last Updated: 2008-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2008-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
No interventions assigned to this group
B
VSL#3 for 4 weeks
VSL#3
A probiotic preparation.
C
Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
VSL#3
A probiotic preparation.
Polyethylene glycol
Oral ingestion of 3 liters of polyethylene glycol solution.
Interventions
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VSL#3
A probiotic preparation.
Polyethylene glycol
Oral ingestion of 3 liters of polyethylene glycol solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signing of informed consent by subject or legal custodian.
3. Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
4. Negative cultures for CRKP from extra-intestinal sites excluding urine.
Exclusion Criteria
2. Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
3. Subjects who are pregnant or breast feeding.
4. 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.
5. Subjects with chronic diarrhea (\>4 weeks).
6. Subjects with inflammatory bowel disease.
7. Subjects whose stool is positive for Clostridium difficile toxin.
8. Subjects receiving immunosuppressive treatment (i.e. corticosteroids; azathioprine or 6-MP; cyclosporine; tacrolimus; OKT3, methotrexate; anti TNF agents; chemotherapy).
9. Subjects who underwent solid organ or hematopoietic stem cell transplantation.
10. Subjects with primary or secondary immunodeficiency disorders, including HIV.
11. Subjects with chronic advanced cardiac, respiratory, renal or liver disease.
12. Subjects with advanced malignant disease.
13. Subjects with severe acute organ failure.
14. Subjects in whom CRKP is isolated from sites other than stool or urine (i.e. blood, sputum or wound cultures).
18 Years
ALL
No
Sponsors
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Tel Aviv University
OTHER
Hadassah Medical Organization
OTHER
Responsible Party
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Hadassah Medical Organization
Principal Investigators
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Maya Margalit, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Arik Tzukert, DMD
Role: primary
Hadas Lamberg, PhD
Role: backup
References
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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. doi: 10.1128/AAC.00299-07. 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. doi: 10.5694/j.1326-5377.2007.tb00995.x.
Other Identifiers
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CRKP-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id