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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
140
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
University of Gondar
Gondar, Region 3, Ethiopia, Gondar, Ethiopia
Change in TB-score compared to baseline (Wejse et al 2007)
Time frame: 2 months
Sputum smear conversion
Time frame: 3 months
Final outcome according to WHO
Time frame: 6 months
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)
Time frame: 3 months
Immunological response (IgE, Eosinophils, CD4-count)
Time frame: 3 months
Chest X-ray improvement
Time frame: 3 months
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