Deworming Against Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857116
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : August 29, 2013
University of Gondar
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Thomas Schon, 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Albendazole Drug: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
Study Start Date : March 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Albendazole

Arm Intervention/treatment
Active Comparator: Albendazole
Albendazole 400mg per os once daily for three consecutive days
Drug: Albendazole
Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Other Name: ALB

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

Primary Outcome Measures :
  1. Change in TB-score compared to baseline (Wejse et al 2007) [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857116

University of Gondar
Gondar, Region 3, Ethiopia, Gondar, Ethiopia
Sponsors and Collaborators
Linkoeping University
University of Gondar
Armauer Hansen Research Institute, Ethiopia
Principal Investigator: Ebba Abate, MSc University of Gondar and Linkoeping University
Principal Investigator: Ermias Diro, MD University of Gondar
Study Director: Thomas Schoen, MD PhD Linkoeping University, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Schon, MD PhD, Linkoeping University Identifier: NCT00857116     History of Changes
Other Study ID Numbers: ALBP
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013

Keywords provided by Thomas Schon, Linkoeping University:

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents