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临床试验/NCT03794284
NCT03794284已完成不适用

Performance of a Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium Tuberculosis and Non-tuberculous Mycobacterium Species in Smear-positive Pulmonary Clinical Specimens

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
diagnostic test correlation

研究概览

简要总结

The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

详细描述

Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are more common to be found in respiratory specimens than MTB. With similar clinical presentation of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the initiation of corresponding treatment.

This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • One or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss
  • One or more sputum samples with positive AFB smear

排除标准

  • Receiving anti-mycobacterial treatment for more than one week
  • Refusal to consent

结局指标

主要结局

diagnostic test correlation

时间窗: 6 months from the date of first recruitment

Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grace Lui

Assistant Professor and Head, Division of Infectious Diseases

Chinese University of Hong Kong

研究点 (1)

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