NCT00023439

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

Study of the Performance of Several Nucleic Acid Amplification Methodologies in the Diagnosis and Management of Active TB

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to evaluate the performance of several nucleic acid amplification methodologies in the diagnosis and management of active tuberculosis

Detailed description

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
OTHER	Nucleic Acid Amplification Methods for diagnosis	no intervention

Timeline

• Start date: 2000-05-01
• First posted: 2001-09-10
• Last updated: 2011-08-03

Locations

14 sites across 4 countries: United States, Canada, South Africa, Uganda