Deworming Against Tuberculosis - Full Text View

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:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Albendazole

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

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 (Adult)
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:

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

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abate E, Elias D, Getachew A, Alemu S, Diro E, Britton S, Aseffa A, Stendahl O, Schön T. Effects of albendazole on the clinical outcome and immunological responses in helminth co-infected tuberculosis patients: a double blind randomised clinical trial. Int J Parasitol. 2015 Feb;45(2-3):133-40. doi: 10.1016/j.ijpara.2014.09.006. Epub 2014 Dec 5.


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	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 26, 2016