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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目的：本研究的目的是确定不同的核酸扩增和肉汤培养试验在预测结核病治疗早期和治疗后复发的有效性。细菌负荷和结核杆菌活性将被测量：在痰中，用定量rRNA，定性(MTD基因探针)rRNA，mRNA；在肉汤培养中，‘阳性时间’；和在循环白细胞中，用结核杆菌DNA。研究计划：研究设计是对在两个多中心结核病治疗试验过程中获得的样本进行盲法回顾评估。这是疾控中心赞助的一项研究。纳入标准是(1)参加TBTC/USPHS试验23或24，以及(2)提供书面知情同意。

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.