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Completed

NCT Number: NCT00857116

Deworming Against Tuberculosis

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gondar

Gondar, Region 3, Ethiopia, Gondar, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole

Drug

Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Other names: ALB

Placebo

Drug

Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Primary outcomes

  1. Change in TB-score compared to baseline (Wejse et al 2007)

    Time frame: 2 months

Secondary outcomes

  1. Sputum smear conversion

    Time frame: 3 months

  2. Final outcome according to WHO

    Time frame: 6 months

  3. Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)

    Time frame: 3 months

  4. Immunological response (IgE, Eosinophils, CD4-count)

    Time frame: 3 months

  5. Chest X-ray improvement

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Armauer Hansen Research Institute, Ethiopia
  • University of Gondar

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2009
Registry last updated
Aug 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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