NCT00722410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 25, 2008

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

July 23, 2008

Last Update Submit

July 24, 2008

Conditions

Anti-Biotic ResistanceKlebsiella Pneumoniae

Keywords

CarbapenemresistantKlebsiella pneumoniaeCarpapenemasesProbioticsVSL3

Outcome Measures

Primary Outcomes (1)

  • A negative stool culture for Carbapenem resistant Klebsiella pneumonia.

    4 weeks.

Secondary Outcomes (1)

  • 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).

    12 weeks beginning of intervention.

Study Arms (3)

A

NO INTERVENTION

B

EXPERIMENTAL

VSL#3 for 4 weeks

Dietary Supplement: VSL#3

C

EXPERIMENTAL

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

Dietary Supplement: VSL#3Drug: Polyethylene glycol

Interventions

VSL#3DIETARY_SUPPLEMENT

A probiotic preparation.

BC
Polyethylene glycolDRUG

Oral ingestion of 3 liters of polyethylene glycol solution.

Also known as: New Meroken., Precolonoscopy solution.
C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (2)

  • 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.

    PMID: 17562800BACKGROUND

  • 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.

    PMID: 17484706BACKGROUND

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Maya Margalit, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Margalit, MD

CONTACT

972-50-7874561mayam@hadassah.org.il

Hadas Lamberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 25, 2008

Record last verified: 2008-07

Locations

IL(1)