Deworming Against Tuberculosis

This study has been completed.
Sponsor:
Collaborators:
University of Gondar
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Thomas Schon, Linkoeping University
ClinicalTrials.gov Identifier:
NCT00857116
First received: March 5, 2009
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention
Tuberculosis
Drug: Albendazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Change in TB-score compared to baseline (Wejse et al 2007) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sputum smear conversion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Final outcome according to WHO [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference in ELIspot pattern (IL5, IFN-gamma and IL-10) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Immunological response (IgE, Eosinophils, CD4-count) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Chest X-ray improvement [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: March 2009
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857116

Locations
Ethiopia
University of Gondar
Gondar, Region 3, Ethiopia, Gondar, Ethiopia
Sponsors and Collaborators
Linkoeping University
University of Gondar
Armauer Hansen Research Institute, Ethiopia
Investigators
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
  More Information

Publications:
Responsible Party: Thomas Schon, MD PhD, Linkoeping University
ClinicalTrials.gov Identifier: NCT00857116     History of Changes
Other Study ID Numbers: ALBP, HLF-20060245
Study First Received: March 5, 2009
Last Updated: August 28, 2013
Health Authority: Ethiopia: Ethical Review Committee
Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Deworming
Tuberculosis
TB-score
Albendazole
Helminths

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

ClinicalTrials.gov processed this record on September 16, 2014