Study Results
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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COMPLETED
NA
140 participants
INTERVENTIONAL
2009-03-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Albendazole
Albendazole 400mg per os once daily for three consecutive days
Albendazole
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
Placebo
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
Placebo
Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Gondar
OTHER
Armauer Hansen Research Institute, Ethiopia
OTHER
Linkoeping University
OTHER_GOV
Responsible Party
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Thomas Schon
MD PhD
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
Countries
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HLF-20060245
Identifier Type: -
Identifier Source: secondary_id
ALBP
Identifier Type: -
Identifier Source: org_study_id