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Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Tel Aviv University
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00722410
First received: July 23, 2008
Last updated: July 24, 2008
Last verified: July 2008
  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 1
Phase 2

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:


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:

  1. Subjects who are > 18 years of age.
  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:

  1. Subjects who have participated in another clinical trial within the last three months.
  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 28, 2014