Multi-center Investigation and Study of Mycoplasma Pneumoniae Infection and Macrolide Drug Resistance in Outpatient and In-hospital Pediatric Acute Respiratory Diseases Illness in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,312
- 主要终点
- MP infection rates
研究概览
简要总结
In recent years, mycoplasma pneumoniae caused more than 30% of respiratory infections in children in China, among which the detection rate of drug-resistant mycoplasma pneumoniae was higher than 90%. Pediatricians are facing great challenges.
In this study, a total of 2312 clinical cases were expected to be collected, including 1160 cases of outpatient respiratory infection including common cold, acute bronchitis and cough after infection, and 1152 cases of hospitalized community-acquired pneumonia, through uniform enrollment in 11 multi-centers for 1 year. Clinical data and respiratory samples were collected and clinical follow-up was completed.To investigate the infection rate and drug resistance gene of mycoplasma pneumoniae in children's respiratory tract infection.To evaluate the effectiveness of azithromycin in the treatment of mycoplasma pneumoniae respiratory infection.The early prediction model of refractory mycoplasma pneumoniae was established.To explore the clinical value of colloidal gold in early diagnosis of mycoplasma pneumoniae infection
详细描述
This research center is a cross-sectional investigation and study, 8 centers including Shanghai children's medical center recruit the outpatient respiratory infection cases into the group, 6 centers including Shanghai children's medical recruit children with community-acquired pneumonia in hospital into the group All of the above cases in the group relevant clinical datas are collected, and complete clinical follow-up.Pharyngeal swabs or sputum specimens collected during the study were sent to Shanghai children's medical center for the detection of MP and macrolidene drug resistance genes.
Azithromycin was administered orally or intravenously to outpatients who tested positive for mycoplasma pneumoniae by colloidal gold method.Finally, MP infection rate of children with respiratory diseases including outpatient (common cold, acute bronchitis and cough after infection) and hospitalization (community-acquired pneumonia) was statistically observed.The detection rate of MP macrolides drug resistance gene was isolated from respiratory disease cases.Sensitivity and specificity of MP rapid detection method (antigen and antibody detection rapid colloidal gold method) for diagnosis of MP infection;Effectiveness of azithromycin in treatment of MRMP infection.
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
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) age: over 28 days, under 18 years old; B) diagnosis: outpatient diagnosis of common cold, acute bronchitis or post-infection cough and hospitalization cases consistent with community-acquired pneumonia.
- •C) the guardian of the child (< 8 years old) or the child (≥8 years old) can understand and be willing to participate in this study and sign a written informed consent.
排除标准
- •A)It is necessary to exclude underlying diseases associated with cardiovascular system, digestive system, nervous system, endocrine system, urinary system, immune system and genetic or chromosomal abnormalities.
- •B) the children or their families refused to participate in the study.
研究组 & 干预措施
Common cold
A cold is a clinical diagnosis.Complaints may include a stuffy nose, sore throat, cough and headache.Objective signs are rare, but may include fever, enlarged anterior cervical lymph nodes, nasal mucosa and oropharyngeal erythema, and nasal mucus.
干预措施: Azithromycin (Drug)
Common cold
A cold is a clinical diagnosis.Complaints may include a stuffy nose, sore throat, cough and headache.Objective signs are rare, but may include fever, enlarged anterior cervical lymph nodes, nasal mucosa and oropharyngeal erythema, and nasal mucus.
干预措施: Mycoplasma detection (Diagnostic Test)
Common cold
A cold is a clinical diagnosis.Complaints may include a stuffy nose, sore throat, cough and headache.Objective signs are rare, but may include fever, enlarged anterior cervical lymph nodes, nasal mucosa and oropharyngeal erythema, and nasal mucus.
干预措施: Data collection (Other)
acute bronchitis
In 2011, the European society of respiratory diseases (ERS) defined acute disease in patients with non-chronic lung disease. Symptoms include cough, with or without expectoration of phlegm, and other symptoms and signs may indicate lower respiratory tract infection and cannot be explained by other diseases (e.g., sinusitis, asthma).The main symptoms of acute bronchitis are cough, may be accompanied by fever, fatigue, asthma and dyspnea.
干预措施: Azithromycin (Drug)
acute bronchitis
In 2011, the European society of respiratory diseases (ERS) defined acute disease in patients with non-chronic lung disease. Symptoms include cough, with or without expectoration of phlegm, and other symptoms and signs may indicate lower respiratory tract infection and cannot be explained by other diseases (e.g., sinusitis, asthma).The main symptoms of acute bronchitis are cough, may be accompanied by fever, fatigue, asthma and dyspnea.
干预措施: Mycoplasma detection (Diagnostic Test)
acute bronchitis
In 2011, the European society of respiratory diseases (ERS) defined acute disease in patients with non-chronic lung disease. Symptoms include cough, with or without expectoration of phlegm, and other symptoms and signs may indicate lower respiratory tract infection and cannot be explained by other diseases (e.g., sinusitis, asthma).The main symptoms of acute bronchitis are cough, may be accompanied by fever, fatigue, asthma and dyspnea.
干预措施: Data collection (Other)
Post-infection cough
The definition in the 2013 guidelines for diagnosis and treatment of chronic cough in Chinese children: cough refers to a recent history of respiratory tract infection;The cough lasted > for 4 weeks, presenting an irritating dry cough or a little white phlegm.Chest x - ray examination showed no abnormality or only increased lung veins.The pulmonary ventilation function was normal, or presented transient high airway response.Coughs are usually self-limited, and other diagnoses should be considered if the cough is more than 8 weeks old.In addition to other causes of chronic cough.
干预措施: Azithromycin (Drug)
Post-infection cough
The definition in the 2013 guidelines for diagnosis and treatment of chronic cough in Chinese children: cough refers to a recent history of respiratory tract infection;The cough lasted > for 4 weeks, presenting an irritating dry cough or a little white phlegm.Chest x - ray examination showed no abnormality or only increased lung veins.The pulmonary ventilation function was normal, or presented transient high airway response.Coughs are usually self-limited, and other diagnoses should be considered if the cough is more than 8 weeks old.In addition to other causes of chronic cough.
干预措施: Mycoplasma detection (Diagnostic Test)
Post-infection cough
The definition in the 2013 guidelines for diagnosis and treatment of chronic cough in Chinese children: cough refers to a recent history of respiratory tract infection;The cough lasted > for 4 weeks, presenting an irritating dry cough or a little white phlegm.Chest x - ray examination showed no abnormality or only increased lung veins.The pulmonary ventilation function was normal, or presented transient high airway response.Coughs are usually self-limited, and other diagnoses should be considered if the cough is more than 8 weeks old.In addition to other causes of chronic cough.
干预措施: Data collection (Other)
community-acquired pneumonia
According to the 2019 guidelines for the diagnosis and treatment of community-acquired pneumonia in children, it is defined as infectious pneumonia developed outside the hospital (community), including pneumonia developed after admission due to infection of pathogens with a clear incubation period outside the hospital (community).
干预措施: non-macrolides antibiotics (Drug)
community-acquired pneumonia
According to the 2019 guidelines for the diagnosis and treatment of community-acquired pneumonia in children, it is defined as infectious pneumonia developed outside the hospital (community), including pneumonia developed after admission due to infection of pathogens with a clear incubation period outside the hospital (community).
干预措施: Mycoplasma detection (Diagnostic Test)
community-acquired pneumonia
According to the 2019 guidelines for the diagnosis and treatment of community-acquired pneumonia in children, it is defined as infectious pneumonia developed outside the hospital (community), including pneumonia developed after admission due to infection of pathogens with a clear incubation period outside the hospital (community).
干预措施: Data collection (Other)
结局指标
主要结局
MP infection rates
时间窗: On enrollment 1 day
Respiratory illnesses include MP infection rates in children with outpatient (common cold, acute bronchitis, and chronic cough) and hospitalized (community-acquired pneumonia).
次要结局
- Sensitivity and specificity of MP rapid detection method(On enrollment 1 day)
- An early prediction model of refractory MP pneumonia(Community acquired pneumonia 30 days after discharge)
- MP macrolides drug resistance gene rate(On enrollment 1 day)
- Clinical efficacy of azithromycin(Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days)