Diagnostic yield of induced sputum for rapid diagnosis of pulmonary tuberculosis

描述（由申请人提供）：这项以社区为基础的横断面研究将测试一种简单低成本的快速诊断肺结核（TB）的诊断方式。我们将测试盐诱导痰是否能提高艾滋病毒感染和未感染艾滋病毒的青少年和成人涂阳结核病的诊断率。它将在我们在南非开普敦附近建立的研究地点进行测试，那里正在进行临床和流行病学研究，为新型结核病疫苗的试验做准备。我们已经成功地使用这种技术对1800多名儿童进行了四期卡介苗试验。具体目的：确定诱导痰是否能改善以下人群中肺结核的微生物学快速诊断：(a)艾滋病毒感染者；(b)所有疑似结核病患者，无论是否感染艾滋病毒。我们将招募600名到社区卫生服务机构就诊的疑似结核病患者。2次常规痰液采集，1次生理盐水雾化诱导痰液采集，1次HIV检测。直接涂片痰液显微镜和分枝杆菌培养将在认可的实验室进行。HIV检测结果将用于对参与者进行分层，以评估主要结果（直接涂片镜检阳性）和次要结果（结核分枝杆菌培养阳性）。将对这些结果进行分析，以一次或两次常规痰液直接涂片显微镜检测到的诊断率（经培养证实的结核病病例的比例）与单次诱导痰相比的差异。2004年，结核病占该区域所有死亡人数的10%。快速诊断肺结核对艾滋病毒感染者尤其重要，因为治疗延误可能是致命的。矛盾的是，在感染艾滋病毒并患有包胞菌病的人中，诊断更为困难。以前的研究已经证明了诱导痰在痰涂片镜检阴性个体中的诊断价值。本研究将通过计算一个高流行率发展中国家的区域结核病控制规划可能实现的诊断收益，客观评估诱导痰对艾滋病毒感染者和未感染艾滋病毒者结核病病例检测的影响。

DESCRIPTION (provided by applicant): This community-based, cross-sectional study will test a simple low-cost diagnostic modality for rapid diagnosis of pulmonary tuberculosis (TB). We shall test whether saline-induced sputum improves the diagnostic yield of smear positive TB in HIV-infected and HIV-uninfected adolescents and adults. It will be tested at our established research site near Cape Town, South Africa, where clinical and epidemiological studies are being conducted in preparation for trials of novel TB vaccines. We have successfully used this technique to investigate over 1,800 children in a Phase IV BCG vaccine trial. Specific aims: To determine whether induced sputum improves rapid microbiological diagnosis of pulmonary TB in: (a) HIV-infected people, and (b), in all people with suspected tuberculosis, regardless of HIV status. We shall enroll 600 patients presenting to community health services with suspected TB. Two routine sputum collections, one induced sputum collection with saline nebulization, and an HIV test will be performed. Direct smear sputum microscopy and mycobacterial culture will be performed in an accredited laboratory. HIV test results will be used to stratify participants for evaluation of the primary outcome, positive direct smear microscopy, and the secondary outcome, positive culture of Mycobacterium tuberculosis. These outcomes will be analyzed as the difference in diagnostic yield (proportion of culture-proven TB cases) detected by direct smear microscopy of one, or two, routine sputum collections, compared to a single induced sputum. TB accounted for 10% of all deaths in this region in 2004. Rapid diagnosis of pulmonary TB is especially critical in HIV-infected individuals, since delay in therapy may be fatal. Paradoxically, diagnosis is more difficult in HIV-infected people with pauci-bacillary disease. Previous studies have demonstrated diagnostic benefit of induced sputum among individuals with negative routine sputum smear microscopy. This study will allow objective assessment of the impact of induced sputum on TB case detection among HIV-infected and HIV-uninfected persons, by calculating the gain in diagnostic yield that might be achieved by a regional TB control program in a high-prevalence developing country.