Deworming Against Tuberculosis

NCT ID: NCT00857116

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis

Keywords

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Deworming Tuberculosis TB-score Albendazole Helminths

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Albendazole

Albendazole 400mg per os once daily for three consecutive days

Group Type ACTIVE_COMPARATOR

Albendazole

Intervention Type DRUG

Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Placebo

Placebo 400mg per os for three consecutive days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Interventions

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Albendazole

Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Intervention Type DRUG

Placebo

Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Intervention Type DRUG

Other Intervention Names

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ALB

Eligibility Criteria

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Inclusion Criteria

* Informed and written consent to take part in the study
* Newly diagnosed pulmonary 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Gondar

OTHER

Sponsor Role collaborator

Armauer Hansen Research Institute, Ethiopia

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Thomas Schon

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebba Abate, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Gondar and Linkoeping University

Ermias Diro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Gondar

Thomas Schoen, MD PhD

Role: STUDY_DIRECTOR

Linkoeping University, Sweden

Locations

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University of Gondar

Gondar, Region 3, Ethiopia, Gondar, Ethiopia

Site Status

Countries

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Ethiopia

References

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Borkow G, Bentwich Z. HIV and helminth co-infection: is deworming necessary? Parasite Immunol. 2006 Nov;28(11):605-12. doi: 10.1111/j.1365-3024.2006.00918.x.

Reference Type BACKGROUND
PMID: 17042932 (View on PubMed)

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. doi: 10.1086/444543. Epub 2005 Aug 25.

Reference Type BACKGROUND
PMID: 16136473 (View on PubMed)

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. doi: 10.1258/004947507782333026.

Reference Type BACKGROUND
PMID: 17988484 (View on PubMed)

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. doi: 10.1111/j.1365-2249.2004.02719.x.

Reference Type BACKGROUND
PMID: 15730384 (View on PubMed)

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. doi: 10.1111/j.1365-3156.2006.01578.x.

Reference Type BACKGROUND
PMID: 16553939 (View on PubMed)

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-Guerin (BCG) vaccination. Clin Exp Immunol. 2001 Feb;123(2):219-25. doi: 10.1046/j.1365-2249.2001.01446.x.

Reference Type BACKGROUND
PMID: 11207651 (View on PubMed)

Abate E, Elias D, Getachew A, Alemu S, Diro E, Britton S, Aseffa A, Stendahl O, Schon T. Effects of albendazole on the clinical outcome and immunological responses in helminth co-infected tuberculosis patients: a double blind randomised clinical trial. Int J Parasitol. 2015 Feb;45(2-3):133-40. doi: 10.1016/j.ijpara.2014.09.006. Epub 2014 Dec 5.

Reference Type DERIVED
PMID: 25486494 (View on PubMed)

Other Identifiers

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HLF-20060245

Identifier Type: -

Identifier Source: secondary_id

ALBP

Identifier Type: -

Identifier Source: org_study_id