A PILOT STUDY TO EVALUATE NUCLEIC ACID AMPLIFICATION TESTS TO PREDICT TB RELAPSE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: The aim of this study is to determine the utility of different nucleic acid amplification and broth culture tests obtained early in treatment and in the post-treatment periods to predict subsequent relapse of tuberculosis. Bacillary burden and MTB viability will be measured: in sputa by quantitative rRNA, qualitative (MTD Gen-Probe) rRNA, mRNA; 'time to positivity' in broth cultures; and in circulating leukocytes ("burry coat" specimens) by MTB DNA. RESEARCH PLAN: The study design is a blinded retrospective evaluation of specimens obtained in the course of two multi-center TB treatment trials. This is a CDC sponsored study. Inclusion criteria are (1) enrollment in TBTC / USPHS Trials 23 or 24, and (2) provision of written informed consent.