Deworming Against Tuberculosis

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857116
• Other study ID #: ALBP
• Secondary ID: HLF-20060245
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: August 28, 2013
• Start date: March 2009
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethical Review CommitteeSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Ethiopia	University of Gondar	Gondar, Region 3, Ethiopia	Gondar

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	Armauer Hansen Research Institute, Ethiopia, University of Gondar

Country where clinical trial is conducted

Ethiopia, 

References & Publications (6)

Borkow G, Bentwich Z. HIV and helminth co-infection: is deworming necessary? Parasite Immunol. 2006 Nov;28(11):605-12. Review. — View Citation

Elias D, Akuffo H, Thors C, Pawlowski A, Britton S. Low dose chronic Schistosoma mansoni infection increases susceptibility to Mycobacterium bovis BCG infection in mice. Clin Exp Immunol. 2005 Mar;139(3):398-404. — View Citation

Elias D, Mengistu G, Akuffo H, Britton S. Are intestinal helminths risk factors for developing active tuberculosis? Trop Med Int Health. 2006 Apr;11(4):551-8. — View Citation

Elias D, Wolday D, Akuffo H, Petros B, Bronner U, Britton S. Effect of deworming on human T cell responses to mycobacterial antigens in helminth-exposed individuals before and after bacille Calmette-Guérin (BCG) vaccination. Clin Exp Immunol. 2001 Feb;123(2):219-25. — View Citation

Kassu A, Mengistu G, Ayele B, Diro E, Mekonnen F, Ketema D, Moges F, Mesfin T, Getachew A, Ergicho B, Elias D, Wondmikun Y, Aseffa A, Ota F. HIV and intestinal parasites in adult TB patients in a teaching hospital in Northwest Ethiopia. Trop Doct. 2007 Oct;37(4):222-4. — View Citation

Modjarrad K, Zulu I, Redden DT, Njobvu L, Lane HC, Bentwich Z, Vermund SH. Treatment of intestinal helminths does not reduce plasma concentrations of HIV-1 RNA in coinfected Zambian adults. J Infect Dis. 2005 Oct 1;192(7):1277-83. Epub 2005 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TB-score compared to baseline (Wejse et al 2007)		2 months	No
Secondary	Sputum smear conversion		3 months	No
Secondary	Final outcome according to WHO		6 months	No
Secondary	Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)		3 months	No
Secondary	Immunological response (IgE, Eosinophils, CD4-count)		3 months	No
Secondary	Chest X-ray improvement		3 months	No