This is a pilot study to evaluate the performance of several nucleic acid amplification methodologies in the diagnosis and management of active tuberculosis
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.
Study Type
OBSERVATIONAL
Enrollment
300
no intervention
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States
LA County/USC Medical Center
Los Angeles, California, United States
University of California, San Francisco
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San Francisco, California, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Chicago-Lakeside VAMC
Chicago, Illinois, United States
Harlem Hospital Center
New York, New York, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
Audi L. Murphy VA Hospital
San Antonio, Texas, United States
Seattle King County Health Department
Seattle, Washington, United States
...and 4 more locations