Status:
COMPLETED
A Cluster-Randomized Trial of DOTS vs DOTS Plus Active Case Finding
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Tuberculosis
Eligibility:
All Genders
Up to 99 years
Brief Summary
The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB) works better than another in reducing new cases of TB. The first plan is the DOTS program, which provides ...
Detailed Description
Tuberculosis (TB) continues to be a major cause of morbidity and mortality worldwide, particularly in developing countries. The World Health Organization (WHO) has estimated that one-third of the worl...
Eligibility Criteria
Inclusion
- All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity. In the DOTS+ACF communities, all households will be surveyed and symptomatic subjects will provide sputum specimens. The subjects will be males and females with no restriction on age, with and without active TB, and living in communities with a high prevalence of TB.
- There will be no exclusion of women or minorities in this study. Pregnant women will be included if they have TB or live in a household with a TB case.
- Children will be included if they have TB per routine practice and will be surveyed in the DOTS+ACF arm for symptoms with their parent's verbal permission and presence.
Exclusion
- All residents of the 20 selected communities will be eligible to participate in the study. Consent will not be requested for DOTS, because this is now the standard of care for the area. Verbal consent will be requested for use of household data to analyze the effectiveness of active case finding. However, even households that refuse to participate in the survey (which is extremely unlikely because this is part of the routine survey in which all households currently participate) will be included when calculating TB incidence for the community.
Key Trial Info
Start Date :
July 10 2007
Trial Type :
OBSERVATIONAL
End Date :
June 1 2012
Estimated Enrollment :
200000 Patients enrolled
Trial Details
Trial ID
NCT00414882
Start Date
July 10 2007
End Date
June 1 2012
Last Update
January 31 2019
Active Locations (1)
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1
Municipal Health Department
Rio de Janeiro, Brazil, 21945