Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Anti-Biotic Resistance Clinical Trial

Official title:

Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00722410
• Other study ID #: CRKP-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 23, 2008
• Last updated: July 24, 2008
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2008
• Source: Hadassah Medical Organization
• Contact: Maya Margalit, MD
• Phone: 972-50-7874561
• Email: mayam[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anti-Biotic Resistance
• Klebsiella Infections
• Klebsiella Pneumoniae
• Pneumonia

Intervention

Dietary Supplement:
• VSL#3
A probiotic preparation.

Drug:
• Polyethylene glycol
Oral ingestion of 3 liters of polyethylene glycol solution.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & 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. Epub 2007 Jun 11. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A negative stool culture for Carbapenem resistant Klebsiella pneumonia.		4 weeks.	No
Secondary	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.	No