Deworming Against Tuberculosis
The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
2 other identifiers
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 29, 2013
August 1, 2013
4.3 years
March 5, 2009
August 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in TB-score compared to baseline (Wejse et al 2007)
2 months
Secondary Outcomes (5)
Sputum smear conversion
3 months
Final outcome according to WHO
6 months
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)
3 months
Immunological response (IgE, Eosinophils, CD4-count)
3 months
Chest X-ray improvement
3 months
Study Arms (2)
Albendazole
ACTIVE COMPARATORAlbendazole 400mg per os once daily for three consecutive days
Placebo
PLACEBO COMPARATORPlacebo 400mg per os for three consecutive days
Interventions
Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linkoeping Universitylead
- University of Gondarcollaborator
- Armauer Hansen Research Institute, Ethiopiacollaborator
Study Sites (1)
University of Gondar
Gondar, Region 3, Ethiopia, Gondar, Ethiopia
Related Publications (7)
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.
PMID: 17042932BACKGROUNDModjarrad 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.
PMID: 16136473BACKGROUNDKassu 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.
PMID: 17988484BACKGROUNDElias 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.
PMID: 15730384BACKGROUNDElias 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.
PMID: 16553939BACKGROUNDElias 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.
PMID: 11207651BACKGROUNDAbate 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.
PMID: 25486494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
August 29, 2013
Record last verified: 2013-08