Deworming Against Tuberculosis

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ClinicalTrials.gov Identifier: NCT00857116

Recruitment Status : Completed

First Posted : March 6, 2009

Last Update Posted : August 29, 2013

Sponsor:

Collaborators:

University of Gondar

Armauer Hansen Research Institute, Ethiopia

Information provided by (Responsible Party):

Thomas Schon, Linkoeping University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tuberculosis	Drug: Albendazole Drug: Placebo	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Supportive Care
Official Title:	The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
Study Start Date :	March 2009
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Drug Information available for: Albendazole

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Albendazole 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 Other Name: ALB
Placebo Comparator: Placebo 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

Outcome Measures

Primary Outcome Measures :

Change in TB-score compared to baseline (Wejse et al 2007) [ Time Frame: 2 months ]

Secondary Outcome Measures :

Sputum smear conversion [ Time Frame: 3 months ]
Final outcome according to WHO [ Time Frame: 6 months ]
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10) [ Time Frame: 3 months ]
Immunological response (IgE, Eosinophils, CD4-count) [ Time Frame: 3 months ]
Chest X-ray improvement [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857116

Locations


Ethiopia
University of Gondar
Gondar, Region 3, Ethiopia, Gondar, Ethiopia

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:	Ermias Diro, 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abate E, Elias D, Getachew A, Alemu S, Diro E, Britton S, Aseffa A, Stendahl O, Schön 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.


Responsible Party:	Thomas Schon, MD PhD, Linkoeping University
ClinicalTrials.gov Identifier:	NCT00857116 History of Changes
Other Study ID Numbers:	ALBP HLF-20060245
First Posted:	March 6, 2009 Key Record Dates
Last Update Posted:	August 29, 2013
Last Verified:	August 2013

Keywords provided by Thomas Schon, Linkoeping University:


Deworming Tuberculosis TB-score Albendazole Helminths

Additional relevant MeSH terms:


Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Albendazole Anthelmintics Antiparasitic Agents Anti-Infective Agents	Anticestodal Agents Antiplatyhelmintic Agents Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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