Deworming Against Tuberculosis - Full Text View

Sponsors and Collaborators:	Linkoeping University University of Gondar Armauer Hansen Research Institute, Ethiopia
Information provided by:	Linkoeping University
ClinicalTrials.gov Identifier:	NCT00857116

Purpose

The purpose of this study is to investigate whether treatment against intestinal helminths in patients with smear positive tuberculosis undergoing chemotherapy could improve the clinical outcome by enhancing host immunity.

Condition	Intervention
Tuberculosis	Drug: Albendazole Drug: Placebo

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Smear Positive Tuberculosis

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Albendazole

U.S. FDA Resources

Further study details as provided by Linkoeping University:

Primary Outcome Measures:

Change in TB-score compared to baseline (Wejse et al 2007) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Sputum smear conversion rate [ Time Frame: 1.5 month and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Chest X-ray pattern [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Final outcome according to WHO [ Time Frame: 7 month ] [ Designated as safety issue: No ]
Difference in ELIspot pattern (IL5, IFN-gamma and TGF-beta) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Immunological response (IgE, Eosinophils, CD4-count) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Albendazole: Active Comparator Albendazole 400mg per os once daily for three consecutive days	Drug: Albendazole Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Placebo: Placebo Comparator Placebo 400mg per os for three consecutive days	Drug: Placebo Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Detailed Description:

Mycobacterium tuberculosis causing tuberculosis (TB) is a major global public health problem. Because of increasing multi drug resistance and the long treatment period of at least six months, new therapeutic options are urgently needed. In countries like Ethiopia where TB is endemic, chronic worm infection is also highly prevalent. Recent data support that helminth infection might limit the host response against TB by inhibition of the TH1-response that is crucial in controlling the disease. In this study we want to test the hypothesis that Albendazole treatment of patients coinfected with helminths and TB could improve clinical outcome in addition to chemotherapy against TB. Additionally we will investigate the immunological interactions between TB and chronic helminths infection.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed and written consent to take part in the study
Newly diagnosed smear positive TB patients according to the WHO definitions of active tuberculosis who have a positive stool sample for helminths other than Schistosoma spp.

Exclusion Criteria:

Pregnancy
Corticosteroid or antibiotic treatment
Symptomatic (diarrhoea) infection caused by worm infection
Chronic diseases or acute infectious diseases other than TB or HIV
Stool sample positive for Schistosoma spp

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857116

Contacts

Contact: Ebba Abate, MSc	+251 911464024	ebbaabate@yahoo.com
Contact: Endalkachew Melese, MD	+251 911406681	hildanaus@yahoo.com

Locations

Ethiopia, Gondar
University of Gondar	Recruiting
Gondar, Region 3, Ethiopia, Gondar, Ethiopia
Contact: Ebba Abate, MSc +251911464024 ebbaabate@yahoo.com
Contact: Endalkachew Melese, MD +251911406681 hildanaus@yahoo.com
Principal Investigator: Ebba Abate, MSc
Principal Investigator: Endalkachew Melese, MD
Sub-Investigator: Shitaye Alemu, MD
Sub-Investigator: Assefa Getachew, MD
Sub-Investigator: Abraham Assefa, MD PhD
Sub-Investigator: Alermayeho Wurku, PhD
Sub-Investigator: Thomas Schoen, MD PhD
Sub-Investigator: Olle Stendahl, Professor
Sub-Investigator: Jonna Idh, MD
Sub-Investigator: Daniel Elias, PhD

Sponsors and Collaborators

Linkoeping University

University of Gondar

Armauer Hansen Research Institute, Ethiopia

Investigators

Principal Investigator:	Ebba Abate, MSc	University of Gondar and Linkoeping University
Principal Investigator:	Endalkachew Melese, MD	University of Gondar
Study Director:	Thomas Schoen, MD PhD	Linkoeping University, Sweden

More Information

Publications:

Borkow G, Bentwich Z. HIV and helminth co-infection: is deworming necessary? Parasite Immunol. 2006 Nov;28(11):605-12. Review.

Modjarrad K, Zulu I, Redden DT, Njobvu L, Lane HC, Bentwich Z, Vermund SH. Treatment of intestinal helminths does not reduce plasma concentrations of HIV-1 RNA in coinfected Zambian adults. J Infect Dis. 2005 Oct 1;192(7):1277-83. Epub 2005 Aug 25.

Kassu A, Mengistu G, Ayele B, Diro E, Mekonnen F, Ketema D, Moges F, Mesfin T, Getachew A, Ergicho B, Elias D, Wondmikun Y, Aseffa A, Ota F. HIV and intestinal parasites in adult TB patients in a teaching hospital in Northwest Ethiopia. Trop Doct. 2007 Oct;37(4):222-4.

Elias D, Akuffo H, Thors C, Pawlowski A, Britton S. Low dose chronic Schistosoma mansoni infection increases susceptibility to Mycobacterium bovis BCG infection in mice. Clin Exp Immunol. 2005 Mar;139(3):398-404.

Elias D, Mengistu G, Akuffo H, Britton S. Are intestinal helminths risk factors for developing active tuberculosis? Trop Med Int Health. 2006 Apr;11(4):551-8.

Elias D, Wolday D, Akuffo H, Petros B, Bronner U, Britton S. Effect of deworming on human T cell responses to mycobacterial antigens in helminth-exposed individuals before and after bacille Calmette-Guérin (BCG) vaccination. Clin Exp Immunol. 2001 Feb;123(2):219-25.

Responsible Party:	University of Gondar, Ethiopia and Linkoeping University, Sweden. ( Ebba Abate )
Study ID Numbers:	ALBP, HLF-20060245
Study First Received:	March 5, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00857116 History of Changes
Health Authority:	Ethiopia: Ethical Review Committee; Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:

Deworming
Tuberculosis
TB-score
Albendazole
Helminths

Study placed in the following topic categories:

Albendazole
Bacterial Infections
Anti-Infective Agents
Gram-Positive Bacterial Infections
Tubulin Modulators

Mycobacterium Infections
Anthelmintics
Tuberculosis
Antimitotic Agents
Helminthiasis

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiplatyhelmintic Agents
Mitosis Modulators
Anthelmintics
Antimitotic Agents
Actinomycetales Infections

Pharmacologic Actions
Anticestodal Agents
Albendazole
Gram-Positive Bacterial Infections
Antiparasitic Agents
Therapeutic Uses
Tubulin Modulators
Mycobacterium Infections
Tuberculosis

ClinicalTrials.gov processed this record on September 10, 2009