Ultralow Dose Computed Tomography in Close Contacts at High Risk for Developing Multidrug- or Extensively Drug-resistant Tuberculosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.
研究概览
简要总结
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
详细描述
Multidrug- or extensively resistant tuberculosis tuberculosis is a major public health threat worldwide and the global burden of drug-resistant tuberculosis is increasing. Drug-resistant tuberculosis is associated with long period and high costs for treatment, high rates of default, treatment failure and death.
Drug-resistant tuberculosis should be diagnosed rapidly so as to reduce potential transmission. In the United States, at least one-fifths cases of multidrug-resistant tuberculosis can be linked to transmission. Close contacts to drug-resistant tuberculosis are at high risk for being transmitted and developing drug-resistant tuberculosis. There are two options suggested for close contacts to drug-resistant tuberculosis: preventive therapy and close observation. But both strategies are lack of sufficient evidence.
Ultralow chest CT scan may be an alternative for early identification and risk stratification of developing active tuberculosis in close contacts to drug-resistant tuberculosis with minimal radiation exposure similar to that of chest x-ray.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who had household contact with or who had worked in the same rooms as patients with smear-positive, culture-proven multidrug-or extensively drug-resistant pulmonary tuberculosis for longer than 8 hours per day
- •Older than 20 years
排除标准
- •Pregnant women
- •Individuals with abnormality on chest x-ray suspected of active tuberculosis
研究组 & 干预措施
Chest CT scan
Two follow-up ultralow dose chest CT scans will be taken 3 months and 1 year after the initial ultralow dose chest CT scan in close contact at high risk for developing multidrug- or extensively drug-resistant tuberculosis.
干预措施: Ultralow dose chest CT scan (Radiation)
结局指标
主要结局
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.
时间窗: 3 months and 1 year after the initial CT scanning
次要结局
未报告次要终点
研究者
Jin Mo Goo
Professor, Department of Radiology
Seoul National University Hospital