Status:
COMPLETED
A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Tuberculosis
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This study will test the effectiveness of two different tuberculosis (TB) prevention strategies, DOTS or DOTS-A. DOTS is the current prevention strategy for TB. DOTS-A is an enhanced prevention strate...
Detailed Description
This will be a single site, prospective, community-randomized trial to study the effectiveness for two TB prevention strategies on the community incidence of TB: DOTS versus Enhanced DOTS (DOTS-Amplia...
Eligibility Criteria
Inclusion
- Cases will include:
- Any age male or female with new or recurrent diagnosis of TB
- Willingness and ability to adhere to study medications and protocol procedures.
- Willingness to provide signed informed consent or signed informed consent/assent provided by parent or legal guardian.
- Contacts will include:
- Male or female living in household of a pulmonary TB case, at high risk for developing TB (but without evidence for active TB).
- High-risk household contacts will be defined as those who are:
- HIV seropositive, regardless of the results of initial tuberculin skin test (TST)
- TST positive at the time of the first household evaluation. TST positivity will be defined as greater than or equal to 5 mm induration of 5 TU of PPD using the Mantoux method, read between 48 and 72 hours after application.
- TST negative at the time for the first household evaluation and TST positive at the time of the second household evaluation 3 months later.
- Willingness to provide signed informed consent or signed informed consent/assent provided by parent or legal guardian.
Exclusion
- Contacts will be excluded from preventive therapy if:
- Current active clinical tuberculosis-confirmed or suspected
- History of sensitivity/intolerance to any of the study medications
- Evidence of acute hepatitis
- History or laboratory evidence of cirrhosis
- Pregnant females (treatment of latent infection will be deferred)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
6400 Patients enrolled
Trial Details
Trial ID
NCT00317330
Start Date
December 1 2004
End Date
June 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
Municipal Health Department
Rio de Janeiro, Brazil, 21945