RBR-3jpsv2尚未招募未知
ine Probe Assay performance validation as a rapid diagnostic test for resistant tuberculosis in reference centers in Brazil - LPA evaluation
Programa Nacional de Controle da Tuberculose CGPNCT / DEVIT Secretaria de Vigilância em Saúde/Ministério da Saúde0 个研究点开始时间: 2020年10月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18Y 至 —（—）
入选标准
- •Clinical sample from patients with probable drug-resistant pulmonary tuberculosis (TB) according to Brazilian Ministry of Health Standards; Xpert MTB/RIF test positive to sputum sample submitted to LPA-1 test and routine diagnostic procedures (culture and antimicrobial susceptibility test in liquid medium); Sample from patient who has not received treatment regimen for TB sensitive drug or TB-DR/MDR for more than 7 days of the past 30 days; Sample from subject with HIV serological test (positive or negative; if the last documented negative HIV test was performed more than three months before the screening visit, the current serological status should be assessed); Sample from subject aged 18 years or older; Samples from subject with a Karnofsky score of 60 or greater at screening; Subject able to provide their consent by signing in the Informed Consent Form (ICF)
排除标准
- •Samples from patients unwilling to take an HIV test if there is no documented HIV test result within three month; Samples from patients deprived of their liberty; Samples from patients whose Information about whether or not to start anti-TB treatment is not present in the medical records / forms of the participating Health Units or in the notification form; Lung samples with a positive result by Xpert MTB / RIF, in which culture or TS were not performed; Samples from patients with inconclusive results on the LPA1 and /or LPA2 tests; Samples from patients with Mycobacterium tuberculosis (MBT) isolates that do not grow or contaminate in the TS and those identified as non-tuberculous mycobacteria (NTM)
研究者
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