NCT07567911尚未招募不适用
A Prospective Observational Cohort Study Protocol for Disease Severity Stratification and Prognosis Assessment in Patients With Pneumonia
Zhonghao Fang1 个研究点 分布在 1 个国家目标入组 2,700 人开始时间: 2026年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,700
- 试验地点
- 1
研究概览
简要总结
This is a prospective, multicenter observational cohort study involving approximately 2,700 patients, designed to delineate the natural history of pneumonia by tracking the complete clinical course and dynamic multi-omics evolution from the acute phase to recovery; the study aims to quantify severe conversion rates and mortality by comparing baseline characteristics, pathogen distribution, and immune response trajectories between severe and non-severe groups, ultimately revealing the underlying molecular mechanisms of disease progression and optimizing clinical risk stratification strategies.
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
- •Inclusion and
排除标准
- •for Pneumonia Patients 1.1 Inclusion Criteria 1) Age ≥ 18 years old; 2) Meeting the diagnostic criteria for pneumonia (acute onset + new infiltrates on imaging); 3) Time from onset to admission ≤ 72 hours; 4) Signed written informed consent. 1.1.1 Inclusion Criteria for Severe Pneumonia Patients A diagnosis of "severe pneumonia" can be made if one of the main criteria or ≥ 3 of the secondary criteria are met.
- •Main Criteria:
- •① Requires mechanical ventilation with tracheal intubation
- •② Requires vasopressor drugs after aggressive fluid resuscitation for septic shock
- •Secondary Criteria:
- •Respiratory rate ≥ 30 breaths/min
- •PaO₂/FiO₂ ≤ 250 mm Hg
- •Multiple lobe infiltrates
- •Confusion and/or disorientation
- •⑤ Blood urea nitrogen ≥ 20 mg/dL
- •⑥ Leukopenia (WBC < 4×10⁹/L)
- •⑦ Thrombocytopenia (PLT < 100×10⁹/L)
- •⑧ Decreased body temperature (central body temperature < 36 ℃)
- •⑨ Hypotension requiring fluid resuscitation 1.2 Exclusion Criteria
- •End-stage diseases (such as expected survival < 48 hours);
- •Long-term immunosuppressive therapy (prednisone > 20mg/d for more than 3 weeks, or neutropenia after chemotherapy);
- •Pregnant or lactating women.
- •Inclusion and Exclusion Criteria for Patients with Suspected Infection but Negative Pathogen Testing 2.1 Inclusion Criteria
- •Age ≥ 18 years old;
- •Having infection-related symptoms or signs (such as fever, cough, sputum production, elevated white blood cells, etc.), clinically suspected of pneumonia;
- •All pathogen tests are negative within 3 days after admission;
- •Time from onset to admission ≤ 72 hours;
- •Signed written informed consent. 2.2 Exclusion Criteria
- •End-stage diseases (such as expected survival < 48 hours);
- •Long-term immunosuppressive therapy;
- •Pregnant or lactating women;
研究组 & 干预措施
pneumonia
Severe pneumonia
Non-infection control group
研究者
Zhonghao Fang
Doctor
Guangzhou Medical University
研究点 (1)
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