Deworming Against Tuberculosis
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Albendazole
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Tuberculosis focused on measuring Deworming, Tuberculosis, TB-score, Albendazole, Helminths
Eligibility 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
Sites / Locations
- University of Gondar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Albendazole
Placebo
Arm Description
Albendazole 400mg per os once daily for three consecutive days
Placebo 400mg per os for three consecutive days
Outcomes
Primary Outcome Measures
Change in TB-score compared to baseline (Wejse et al 2007)
Secondary Outcome Measures
Sputum smear conversion
Final outcome according to WHO
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)
Immunological response (IgE, Eosinophils, CD4-count)
Chest X-ray improvement
Full Information
NCT ID
NCT00857116
First Posted
March 5, 2009
Last Updated
August 28, 2013
Sponsor
Linkoeping University
Collaborators
University of Gondar, Armauer Hansen Research Institute, Ethiopia
1. Study Identification
Unique Protocol Identification Number
NCT00857116
Brief Title
Deworming Against Tuberculosis
Official Title
The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
University of Gondar, Armauer Hansen Research Institute, Ethiopia
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Deworming, Tuberculosis, TB-score, Albendazole, Helminths
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albendazole
Arm Type
Active Comparator
Arm Description
Albendazole 400mg per os once daily for three consecutive days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 400mg per os for three consecutive days
Intervention Type
Drug
Intervention Name(s)
Albendazole
Other Intervention Name(s)
ALB
Intervention Description
Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Primary Outcome Measure Information:
Title
Change in TB-score compared to baseline (Wejse et al 2007)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Sputum smear conversion
Time Frame
3 months
Title
Final outcome according to WHO
Time Frame
6 months
Title
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)
Time Frame
3 months
Title
Immunological response (IgE, Eosinophils, CD4-count)
Time Frame
3 months
Title
Chest X-ray improvement
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebba Abate, MSc
Organizational Affiliation
University of Gondar and Linkoeping University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ermias Diro, MD
Organizational Affiliation
University of Gondar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Schoen, MD PhD
Organizational Affiliation
Linkoeping University, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
University of Gondar
City
Gondar, Region 3, Ethiopia
State/Province
Gondar
Country
Ethiopia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17042932
Citation
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.
Results Reference
background
PubMed Identifier
16136473
Citation
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.
Results Reference
background
PubMed Identifier
17988484
Citation
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.
Results Reference
background
PubMed Identifier
15730384
Citation
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.
Results Reference
background
PubMed Identifier
16553939
Citation
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.
Results Reference
background
PubMed Identifier
11207651
Citation
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.
Results Reference
background
PubMed Identifier
25486494
Citation
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.
Results Reference
derived
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Deworming Against Tuberculosis
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