Deworming Against Tuberculosis

Linköping University (LiU)

Status: Completed

Conditions: Tuberculosis

Treatments: Drug: Albendazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00857116

HLF-20060245

ALBP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Albendazole

Active Comparator group

Description:

Albendazole 400mg per os once daily for three consecutive days

Treatment:

Drug: Albendazole

Placebo

Placebo Comparator group

Description:

Placebo 400mg per os for three consecutive days

Treatment:

Drug: Placebo