A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Survival at 28 Days
研究概览
简要总结
Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to explore the lower respiratory microenvironment and host immune response and then make an application in clinic.
详细描述
Investigators perform a cross-sectional multicenter study on patients with pulmonary infection. All patients receive clinical questionnaires, laboratory examinations and treatment monitoring. Routine clinical pathogen culture and mNGS are both carried out on pathogen detection. Among participants in IDSeq UltraTM group, 1:2 nested case-control study is carried out involving 77 cases from pulmonary-infected group paired with 154 control cases and peripheral blood RNA-seq is carried out between pneumonia patients with diabetes and pneumonia patients without diabetes matched for gender, age and fasting blood-glucose.
The final purpose is to find out the difference in etiologic spectrum and host immune on lower respiratory infection between diabetes patients and controls. Now investigators wish to register this study to do a further research, in order to improve the diagnosis value of diabetes complicated with pulmonary infection and to reduce the mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Diagnosis by pathogen examination: positive
- •Diagnosis through X-ray or CT: characteristic features of pulmonary infection
- •Age older than 18 years
排除标准
- •Irregular follow-up and lost follow-up
- •Withdraw from the study for any reason
结局指标
主要结局
Survival at 28 Days
时间窗: 28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
28 days from date of diagnosis of pulmonary infection until the date of death from any cause
Survival at 7 Days
时间窗: 7 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
7 days from date of diagnosis of pulmonary infection until the date of death from any cause
Survival at 14 Days
时间窗: 14 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
14 days from date of diagnosis of pulmonary infection until the date of death from any cause
次要结局
- Hospitalization Time(Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years)
- PSI Indexs(Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- 72h Treatment Response(disease treating 72 hours)
- CURB-65 Score(Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years)
- Cell-mediated Immunoserologic Indexs(Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- SOFA Indexs(Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- Inflammatory Parameters(Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
研究者
ZHOU Min
Chief Physician of Department of Respiratory Medicine
Ruijin Hospital