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Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Primary Purpose

Anti-Biotic Resistance, Klebsiella Pneumoniae

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
VSL#3
Polyethylene glycol
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-Biotic Resistance focused on measuring Carbapenem, resistant, Klebsiella pneumoniae, Carpapenemases, Probiotics, VSL3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

A

B

C

Arm Description

VSL#3 for 4 weeks

Mechanical bowel cleansing followed by VSL#3 for 4 weeks.

Outcomes

Primary Outcome Measures

A negative stool culture for Carbapenem resistant Klebsiella pneumonia.

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).

Full Information

First Posted
July 23, 2008
Last Updated
July 24, 2008
Sponsor
Hadassah Medical Organization
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT00722410
Brief Title
Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia
Official Title
Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Biotic Resistance, Klebsiella Pneumoniae
Keywords
Carbapenem, resistant, Klebsiella pneumoniae, Carpapenemases, Probiotics, VSL3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Title
B
Arm Type
Experimental
Arm Description
VSL#3 for 4 weeks
Arm Title
C
Arm Type
Experimental
Arm Description
Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
VSL#3
Intervention Description
A probiotic preparation.
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol
Other Intervention Name(s)
New Meroken., Precolonoscopy solution.
Intervention Description
Oral ingestion of 3 liters of polyethylene glycol solution.
Primary Outcome Measure Information:
Title
A negative stool culture for Carbapenem resistant Klebsiella pneumonia.
Time Frame
4 weeks.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Margalit, MD
Phone
972-50-7874561
Email
mayam@hadassah.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lamberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Margalit, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lamberg, PhD
Phone
: 00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Reut Zaguri, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17562800
Citation
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.
Results Reference
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PubMed Identifier
17484706
Citation
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.
Results Reference
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Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

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