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

July 23, 2008
July 24, 2008
September 2008
September 2010   (final data collection date for primary outcome measure)
A negative stool culture for Carbapenem resistant Klebsiella pneumonia. [ Time Frame: 4 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722410 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia
Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anti-Biotic Resistance
  • Klebsiella Pneumoniae
  • 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.
  • No Intervention: A
  • Experimental: B
    VSL#3 for 4 weeks
    Intervention: Dietary Supplement: VSL#3
  • Experimental: C
    Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
    Interventions:
    • Dietary Supplement: VSL#3
    • Drug: Polyethylene glycol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
September 2010
September 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Maya Margalit, MD 972-50-7874561 mayam@hadassah.org.il
Contact: Hadas Lamberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Israel
 
NCT00722410
CRKP-HMO-CTIL
No
Maya Margalit, Hadassah Medical Organization
Hadassah Medical Organization
Tel Aviv University
Principal Investigator: Maya Margalit, MD Hadassah Medical Organization
Hadassah Medical Organization
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP