Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference in neutrophil CD64 expression
研究概览
简要总结
Cystic fibrosis (CF) is the most common inherited disease in the western world. On a yearly basis, 56% of CF patients, or nearly 17,000 individuals in the US, suffer from acute pulmonary exacerbations (APE). The purpose of this study is to test a candidate assay for its ability to diagnose APE, the most important disease event in CF. While previous studies have been able to identify biomarkers of CF prognosis and risk stratification, three markers have demonstrated characteristics ideal for APE diagnosis: CD64, TLR2, and GILT. CD64 is a cellular receptor, expressed on numerous cells of the immune system, whose role is to bind antibodies which are attached to infected cells or pathogens. TLR2 plays a major role in early host-microbial interactions. GILT has been shown to be more precise in targeting immune responses against antigens and influences T lymphocyte response. This study looks to identify the differences in the expression of neutrophil CD64 and CD4+ T cell TLR2 and GILT between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition. The study also looks to compare sensitivity and specificity of the assays above to standard measures, such as health related quality of life scores (CFQ-R), loss of lung function, white blood cell counts and CRP, for diagnosing acute exacerbations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of CF.
- •Age 18 years old or greater.
- •Presentation at baseline health OR at the start of treatment for a pulmonary exacerbation of CF.
- •Ability to perform reproducible Pulmonary Function Tests
- •Ability to produce sputum.
- •Willingness to complete a health-related quality of life questionnaire
- •Willingness to comply with study procedure and provide written consent.
排除标准
- •Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
结局指标
主要结局
Difference in neutrophil CD64 expression
时间窗: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
The primary outcome measure is the difference in expression of neutrophil CD64 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
Difference in CD4+ T cell TLR2 expression
时间窗: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
The primary outcome measure is the difference in expression of CD4+ T cell TLR2 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
Difference in GILT expression
时间窗: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
The primary outcome measure is the difference in expression of GILT as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
次要结局
- Correlation of primary outcome measurements with lung function tests(Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health)
- Correlation of primary outcome measurements with C-Reactive Protein(Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health)
- Correlation of primary outcome measurements with sputum inflammatory markers(Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health)
- Correlation of primary outcome measurements with phagocytosis(Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health)
- Correlation of primary outcome measurements with total white blood cell counts(Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health)
- Correlation of primary outcome measurements with quality of life questionnaire score(Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health)