Deworming Against Tuberculosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis

Conditions
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Tuberculosis

Intervention / Treatment
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* Drug: Albendazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albendazole<br>Albendazole 400mg per os once daily for three consecutive days | Drug: Albendazole<br>* Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis<br>* Other names: ALB;|
| Placebo Comparator: Placebo<br>Placebo 400mg per os for three consecutive days | Drug: Placebo<br>* Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TB-score compared to baseline (Wejse et al 2007) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 3 months | 
| Immunological response (IgE, Eosinophils, CD4-count) |  | 3 months | 
| Chest X-ray improvement |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deworming, Tuberculosis, TB-score, Albendazole, Helminths