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
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
- 否
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
Grace Lui
Assistant Professor and Head, Division of Infectious Diseases
Chinese University of Hong Kong
