Deworming Against Tuberculosis
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ClinicalTrials.gov Identifier: NCT00857116 |
Recruitment Status
:
Completed
First Posted
: March 6, 2009
Last Update Posted
: August 29, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Drug: Albendazole Drug: Placebo | Not Applicable |
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 |

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
|
- Change in TB-score compared to baseline (Wejse et al 2007) [ Time Frame: 2 months ]
- Sputum smear conversion [ Time Frame: 3 months ]
- Final outcome according to WHO [ Time Frame: 6 months ]
- Difference in ELIspot pattern (IL5, IFN-gamma and IL-10) [ Time Frame: 3 months ]
- Immunological response (IgE, Eosinophils, CD4-count) [ Time Frame: 3 months ]
- Chest X-ray improvement [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (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

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 ClinicalTrials.gov identifier (NCT number): NCT00857116
Ethiopia | |
University of Gondar | |
Gondar, Region 3, Ethiopia, Gondar, 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Thomas Schon, MD PhD, Linkoeping University |
ClinicalTrials.gov Identifier: | NCT00857116 History of Changes |
Other Study ID Numbers: |
ALBP HLF-20060245 |
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:
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 |