Deworming Against Tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Drug: Placebo; Drug: Albendazole

• Registration Number: NCT00857116
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2013-06
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 400mg per os for three consecutive days
Albendazole	Albendazole	Albendazole 400mg per os once daily for three consecutive days

Primary Outcome Measures

Name	Time	Method
Change in TB-score compared to baseline (Wejse et al 2007)	2 months

Secondary Outcome Measures

Name	Time	Method
Final outcome according to WHO	6 months
Chest X-ray improvement	3 months
Sputum smear conversion	3 months
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)	3 months
Immunological response (IgE, Eosinophils, CD4-count)	3 months

Trial Locations

Locations (1)

University of Gondar; 🇪🇹 Gondar, Region 3, Ethiopia, Gondar, Ethiopia