NCT06028217尚未招募不适用
A Prospective Study on Pathogen Investigation, Risk Factors, and Prognostic Factors Analysis of Hospital Acquired Pneumonia (HAP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,000
- 主要终点
- mortality at day 28
研究概览
简要总结
The goal of this prospective and observatory study is to learn about the pathogen, clinical manifestations, prognosis, treatment and antibiotic resistance of bacteria in hospital-acquired pneumonia patients in China.
The main purposes of this study are:
- clarify the regional differences and changes over time in the pathogen spectrum and antibiotic resistance rate among HAP patients in China;
- build a continuously optimized nationwide HAP pathogen and antibiotic resistance surveillance network;
- identify the molecular epidemiology of common pathogens
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Meets the clinical diagnostic criteria for HAP in the 2018 HAP/VAP guidelines. Chest X-ray or CT shows new or progressive infiltrative shadows, consolidation shadows, or ground glass shadows, combined with 2 or more of the following 3 clinical symptoms, to establish a clinical diagnosis: 1) Fever, body temperature>38 ℃; 2) Purulent airway secretions; 3) Peripheral blood white blood cell count >10 × 10^9/L or <4 × 10^9/L.
- •Having qualified evidence of responsible pathogen. On the basis of clinical diagnosis, one of the following conditions should be met simultaneously: 1) Qualified lower respiratory tract secretions (neutrophil count >25/low magnification field, epithelial cell count <10/low magnification field, or a ratio of the two >2.5:1), pathogenic bacteria cultured through bronchoscopy anti pollution brush (PSB), bronchoalveolar lavage fluid (BALF), lung tissue or sterile body fluid, and consistent with clinical manifestations; 2) Pathology, cytopathology, or direct microscopic examination of lung tissue specimens showing fungi and evidence of tissue damage; 3) The serum IgM antibodies of atypical pathogens or viruses change from negative to positive, or the titers of specific IgG antibodies in both acute and recovery phases show a 4-fold or more change. During the outbreak of respiratory viruses and with a history of epidemiological contact, respiratory secretions were tested positive for corresponding virus antigens, nucleic acid tests, or virus culture.
- •obtained informed consent
排除标准
- •Those who cannot understand and execute the investigation plan.
- •Active pulmonary tuberculosis;
- •Severely immunosuppressed patients: absolute neutrophil count <0.5× 10^9/L, CD4<200/ml.
结局指标
主要结局
mortality at day 28
时间窗: 28 days after enrollment
prognosis
次要结局
- pathogen(0 day, 3 days, 7days, 14 days and 28 days after enrollment)
- clinical characteristics(0 day, 3 days, 7days, 14 days and 28 days after enrollment)
研究者
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