Tuberculosis
Conditions
Keywords
Deworming, Tuberculosis, TB-score, Albendazole, Helminths
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.
Interventions
DRUGAlbendazole
Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
DRUGPlacebo
Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Sponsors
University of Gondar
Armauer Hansen Research Institute, Ethiopia
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in TB-score compared to baseline (Wejse et al 2007) | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Ethiopia
Outcome results
None listed