NCT04552015终止不适用
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
The HIV Netherlands Australia Thailand Research Collaboration1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年4月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- size of induration at 48 hours post-PPD injection
研究概览
简要总结
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
详细描述
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex : Male and Female
- •Age : 20-60 years
- •TB contacts or those at risk of TB e.g. health-care workers
- •HIV-negative healthy individuals
排除标准
- •Presence of an acute infection, as determined by investigators
- •Receiving immunosuppression drugs e.g. steroids
- •Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
- •Being pregnant or breastfeeding
研究组 & 干预措施
volunteers
Other
two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection
干预措施: TST vs PPD microneedle test (Diagnostic Test)
结局指标
主要结局
size of induration at 48 hours post-PPD injection
时间窗: 48 hours
Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests
次要结局
未报告次要终点
研究者
研究点 (1)
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