A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis
Tuberculosis
About this trial
This is an interventional treatment trial for Tuberculosis
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Sites / Locations
- Municipal Health Department