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| ID | Type | Description | Link |
|---|---|---|---|
| HLF-20060245 |
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| Name | Class |
|---|---|
| University of Gondar | OTHER |
| Armauer Hansen Research Institute, Ethiopia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albendazole | Active Comparator | Albendazole 400mg per os once daily for three consecutive days |
|
| Placebo | Placebo Comparator | Placebo 400mg per os for three consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TB-score compared to baseline (Wejse et al 2007) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum smear conversion | 3 months | |
| Final outcome according to WHO | 6 months | |
| Difference in ELIspot pattern (IL5, IFN-gamma and IL-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebba Abate, MSc | University of Gondar and Linkoeping University | Principal Investigator |
| Ermias Diro, MD | University of Gondar | Principal Investigator |
| Thomas Schoen, MD PhD | Linkoeping University, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Gondar | Gondar, Region 3, Ethiopia | Gondar | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17042932 | Background | 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. | |
| 16136473 | Background | 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. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis |
|
| 3 months |
| Immunological response (IgE, Eosinophils, CD4-count) | 3 months |
| Chest X-ray improvement | 3 months |
| 17988484 | Background | 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. |
| 15730384 | Background | 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. |
| 16553939 | Background | 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. |
| 11207651 | Background | 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. |
| 25486494 | Derived | 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |