A Study on Pathogenic Surveillance and Nasopharyngeal Carriage of Children and Adolescents Based on Hospitals and Communities in Hainan Province
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,746
- 试验地点
- 5
- 主要终点
- Correaltion index of disease status of infection with different pathogens
研究概览
简要总结
This study intends to screen children under the age of 10 for respiratory pathogens, Streptococcus pneumoniae, and serotyping in three representative cities in Hainan province: Haikou, Wanning, and Baisha, in order to provide a foundation for the subsequent promotion of Streptococcus pneumoniae vaccines.
详细描述
The purpose of this multi-center epidemiological study was to determine the carrier status of clinically diagnosed pneumonia, pathogen spectrum of clinically diagnosed pneumonia, serotype distribution, and drug resistance profile of Streptococcus pneumoniae in sick children from hospitals and healthy children from the community.
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
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case group: patients from fever clinics and pediatric wards
- •Patients with at least one of the following will be clinically diagnosed with pneumonia and recommended for NP/OP, blood cultures, or induced sputum as clinically indicated (TB only or if performed routinely by the clinician), bronchoalveolar lavage fluid (BALF , according to clinical requirements), pleural effusion (according to clinical requirements), and chest X-ray examination:
- •Shortness of breath ( children <2 months, respiratory rate ≥60 breaths/min; children ≥2 months to <12 months, respiratory rate ≥50 breaths/min; children ≥12 months to < 60 months, respiratory rate ≥40 breaths/min; Children ≥ 60 months to < 120 months, respiratory rate > 24 breaths/minute )
- •Rales on lung auscultation
- •Respiratory symptoms and fever ( axillary temperature ≥ 37.5 ℃ or rectal temperature ≥ 38 ℃ )
- •Control group The control group will be randomly selected from the community and frequency-matched 1:1 with the case group according to age group, sex and city.
排除标准
- •Hospitalized within the first 14 days, or discharged as a case group within the first 30 days, and lived outside the research center area ;
- •People who affect the research results: patients cannot keep samples or the amount of samples is not enough for testing;
- •Can't cooperate well;
- •The researcher judges that it is not suitable to be included in this study .
结局指标
主要结局
Correaltion index of disease status of infection with different pathogens
时间窗: 1 day
Estimate the association with disease status of infection with pathogens of interest (or combination of pathogens) among children aged\<10 years old hospitalized with clinical diagnosed pneumonia compared to healthy children in the community in Hainan. The study is designed to be the case-control study
Prevalence of pneumococcus
时间窗: 1 day
Estimate the prevalence of pneumococcus among children aged\<10 years old hospitalized with clinical diagnosed pneumonia, in children seen at outpatient clinics, and among healthy children in the community in Hainan
Correaltion index of high load (>6.9 log10 copies/ml) pneumococcus
时间窗: 1 day
Estimate the association with disease (i.e., case-control status) of high load (\>6.9 log10 copies/ml) pneumococcus among outpatient or hospitalized patients with clinical diagnosed pneumonia in children aged\<10 years old and among healthy children in the community in Hainan
次要结局
- Estimate the proportions of srotypes in patients and healthy children(1 day)
- Describe the resistance proportion of antibiotics in different region in Hainan(1 day)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases Affiliation: Huashan Hospital
Huashan Hospital