Status:
UNKNOWN
Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Tel Aviv University
Conditions:
Anti-Biotic Resistance
Klebsiella Pneumoniae
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00722410
Start Date
September 1 2008
End Date
September 1 2010
Last Update
July 25 2008
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120