TBTC NAA Study: Pilot Study of Surrogate Markers for Outcome of TB Treatment

This study evaluates potential surrogate markers of treatment failure and relapse as a
substudy of ongoing Tuberculosis Trials Consortium (TBTC) disease treatment studies. After
enrollment is complete, specimens from cases of treatment failure and relapse will be
evaluated in comparison to control samples to measure the prognostic value of the following
tests: 1) quantitative rRNA in 2-month sputum to predict relapse, 2) MTB 85B mRNA to detect
reactivation, 3) 1- to 4-month NAA and broth culture tests to predict relapse, 4) mRNA, rRNA
and DNA at and after end of therapy to predict relapse, 5)sputum rRNA and blood DNA to
detect recurrence during prodrome, 6) sputum rRNA compared to cultures to diagnose
"paradoxical reactions," 7) compare blood DNA to cultures at end of induction and end of
treatment, 8) compare accuracies of different NAA assays and standard cultures, 9) determine
MTD rRNA assay positive to negative conversion time, 10) characterize quality and quantity
of sputum over time in relation to culture and clinical outcome, 11) assess ability of
clinical, radiographic, and microbiologic risk factors to predict treatment failure and
relapse.