Global Consortium for Drug-resistant Tuberculosis Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,128
- 试验地点
- 3
- 主要终点
- Time to completion of rapid diagnostic assays
研究概览
简要总结
The goal of this study is to evaluate time to diagnosis for three assays (line probe, pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect resistance to first and second-line anti-tuberculosis (TB) drugs in Mycobacterium tuberculosis (Mtb) strains in 7 days or less, allowing for rapid diagnosis of extensively drug-resistant TB (XDR-TB).
详细描述
The goals of this study are to test, fine tune, and compare three tests (line probe, pyrosequencing, MODS assays) to rapidly detect Mycobacterium tuberculosis (Mtb) strains that are resistant to first and second-line anti-tuberculosis (TB) drugs allowing for rapid diagnosis of Extensively Drug-Resistant Tuberculosis (XDR-TB).
Primary Specific Aims
Aim 1: To reduce the average XDR-TB detection time from months to a week.
Aim 2: To determine agreement between rapid tests and standard drug susceptibility testing (DST) results.
Aim 3: To identify the genetic basis of discordant results from Aim 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 5 years of age
- •Known to be acid fast bacilli (AFB) sputum smear-positive, 1+ or greater (within prior 14 days), positive on GeneXpert, or present clinically with high suspicion of active TB and:
- •Had previously received >1 month of treatment for a prior TB episode or
- •Were failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
- •Had had close contact with a known drug-resistant TB case or
- •Were newly diagnosed with multi-drug resistant TB (MDR-TB) within the last 30 days or
- •Were previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen
- •Provided informed consent or had ability and willingness of subject or legal guardian/representative to provide informed consent
排除标准
- •Institutionalized
- •Unable to provide at least 7.5ml sputum (1st and 2nd samples combined)
- •Had results from second line DST performed within the last 3 months
结局指标
主要结局
Time to completion of rapid diagnostic assays
时间窗: Up to 83 weeks
Time to completion was calculated from date of initial sputum collection to completion of each rapid diagnostic assay. Time frame for analysis of all results was from date of first patient recruited till 21 weeks after last patient recruited (total 83 weeks).
次要结局
未报告次要终点
研究者
Antonino Catanzaro
Professor
University of California, San Diego