Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission
试验速览
- 阶段
- 不适用
- 入组人数
- 11,060
- 试验地点
- 1
- 主要终点
- Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers.
研究概览
简要总结
The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis (TB) infection control known as FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively). It is anticipated that this will decrease time to effective treatment initiation and also decrease transmission of TB to health care workers.
详细描述
There is longstanding evidence that tuberculosis (TB) transmission is not from TB patients on effective treatment, but from unsuspected cases, and cases with unsuspected drug resistance. This study seeks to investigate the implementation of a refocused TB transmission control approach that we call FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively based on molecular drug-susceptibility testing [DST]). We will conduct this study at Hospital Nacional Hipólito Unanue in Lima, Peru. Our hypothesis is that FAST will reduce delays in identifying infectious TB patients (and unsuspected drug resistance) entering the hospital, facilitate timely effective therapy, and thereby reduce the risk of TB transmission in a cost-effective manner. We will assess the impact of FAST on TB transmission by evaluating IGRA conversions among health care workers at the intervention site, Hospital Nacional Hipolito Unanue (HNHU), and two control sites, Hosptial Nacional Arzobispo Loayza (HNAL) and Hospital Nacional Sergio Bernales (HNSB). We will also evaluate acceptability and barriers to/facilitators of FAST, novel screening strategies, and health care worker IGRA testing using a mixed methods approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FAST Implementation
This single center study will consist of introducing a TB screening program called FAST (Find cases Actively, Separate safely, and Treat Effectively) within the hospital among patients presenting for care who have cough or TB risk factors, and testing them for tuberculosis using a combination of rapid screening and diagnostics tools. The study will evaluate the process of implementation as well as the impact on reducing tuberculosis transmission to health care workers over successive years.
干预措施: FAST (Other)
结局指标
主要结局
Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers.
时间窗: 5 years
Time to diagnosis and Time to effective treatment initiation
次要结局
- Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis.(5 years)
- Sensitivity and specificity of a novel exhaled breath test (EBT) and digital chest X-ray with computer assisted detection (dCXR/CAD4TB) as "rule-out" screening tests for tuberculosis in coughing patients(5 years)
- Costs and cost-effectiveness of FAST(5 years)
研究者
Edward Anthony Nardell, MD
Associate Physician
Brigham and Women's Hospital