A Prospective, Single-Center Clinical Validation Study of Transcri Ptomics-Based Biomarkers for Predicting Respiratory Infection Progression and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.
研究概览
简要总结
This study adopted a prospective, single-center, open-label design, aiming to evaluate the efficacy of the RTI clinical outcome prediction model in predicting clinical outcomes in subjects with acute respiratory tract infections.
In this study, the subjects were divided into the community-acquired pneumonia group and the sepsis group, including one baseline visit, one visit on the 7th day, and one visit on the 28th day.
During the research process, blood samples will be collected at the corresponding visiting points for the validation of the predictive model.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-acquired pneumonia group
- •Age ≥18 years old;
- •Sign the informed consent form; ③ According to the researcher's judgment, be able to comply with the research visit; ④ Comply with the diagnostic criteria for community-acquired pneumonia in the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults (2016 Edition); ⑤ The time from onset to enrollment was ≤8 days. Sepsis Group
- •Age ≥18 years old;
- •Sign the informed consent form; ③ According to the researcher's judgment, be able to comply with the research visit;
- •Patients who meets the sepsis 3.0 diagnostic criteria.
排除标准
- •Exclusion criteria
- •Respiratory failure related to underlying heart and lung diseases;
- •Severe liver and kidney dysfunction, pregnancy or lactation period;
- •Meet the indications for organ transplantation or have undergone organ transplantation surgery in the past; ④ Known HIV infection; ⑤ Screening: Those who have experienced unstable angina pectoris or myocardial infarction within 30 days prior to the screening and have not received vascular recanalization treatment, as well as those with extensive cerebral hemorrhage; ⑥ Situations where researchers determine that enrollment is not appropriate.
结局指标
主要结局
Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.
时间窗: From enrollment to the end of follow-up at 28 days
次要结局
- The changes of the seven-scale compared to the time of enrollment(From enrollment to the end of follow-up at 28 days)
- The changes in SOFA score compared to the time of enrollment.(From enrollment to the end of follow-up at 28 days)
研究者
Xinlun Tian
Chief physician, professor
Peking Union Medical College Hospital