Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- Evaluate alternative methods for the detection of microbial pathogens from the lungs of people with CF by comparing against the gold standard of sputum cultures.
研究概览
简要总结
Sputum culture has been the best approach to detect harmful bacteria in the lungs of people with cystic fibrosis (CF). With the widespread use of new CF therapies (like Trikafta and Alyftrak), it is more difficult for people with CF to produce sputum even though they still have harmful bacteria in their lungs. The SEND-CF study is being done to see if there are other ways to detect harmful bacteria in the lungs.
详细描述
People with cystic fibrosis (CF) often get lung infections that can make their breathing worse and make their lungs weaker over time. Sputum culture is usually analyzed to find these infections. Currently, many people with CF are using CFTR modulators. These medicines help, but they also make it harder for people to cough up sputum. Even though people with CF are making less sputum, lung infections are still a problem. New ways are needed to check for infections without using sputum.
The SEND-CF study wants to gather health information and samples from people with CF in order to find new and better ways to spot harmful bacteria in the lungs. Participants, who typically are able to produce sputum who consent to participate will be asked to provide samples including sputum, saliva, serum, plasma, buffy coat, urine, and whole blood. Some participants will also provide breath samples for a sub-study.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 16 years of age on day of study visit
- •Documentation of CF Diagnosis
- •Able to expectorate sputum
- •Percent predicted FEV1 ≥ 30%
排除标准
- •History of solid organ transplantation
- •History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit
结局指标
主要结局
Evaluate alternative methods for the detection of microbial pathogens from the lungs of people with CF by comparing against the gold standard of sputum cultures.
时间窗: Baseline Visit
Specimens (including sputum, saliva, blood, urine, and breath (for the Owlstone Device Sub-Study)) will be collected at the Study Visit. These specimens will be stored at a biorepository and be made available to the research community to test and validate diagnostic assays for the detection of CF pathogens.
次要结局
未报告次要终点
研究者
Chris Goss
Professor of Medicine and Pediatrics, University of Washington
Seattle Children's Hospital