A Randomized, Double-blind, Parallel-controlled,Multicenter Clinical Study of Xiyanping Injection Combined With Azithromycin and Azithromycin for Children With Pneumonia
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 主要终点
- Clinical recovery time
研究概览
简要总结
Mycoplasma pneumoniae pneumonia in children is one of the major diseases in children's respiratory department in China, but there are still large clinical unmet needs.
详细描述
In order to further verify the clinical value and safety of Xiyanping injection in children with Mycoplasma pneumoniae pneumonia, to provide references for subsequent confirmatory research, and to provide more reasonable and standardized application guidance and basis for clinical practice, we intend to adopt more rigorous Scientific design to carry out a multi-center, randomized, double-blind, parallel-controlled study of Xiyanping injection in the treatment of children with Mycoplasma pneumoniae pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 to 14 years of age at the time of screening;
- •Children who meet the Western medicine clinical diagnosis standard of Mycoplasma pneumoniae and the mycoplasma pneumoniae IgM antibody titer ≥1 : 80, or Mycoplasma pneumoniae DNA or RNA (PCR) test positive, or rapid identification of Mycoplasma pneumoniae antibodies positive;
- •Heat course ≤ 5 days;
- •The total number of peripheral blood routine leukocytes is within the normal range;
- •The child's legal guardian or / and himself voluntarily participate in the study, and the legal guardian agrees and signs the informed consent form (while children ≥8 years of age need to voluntarily sign the informed consent form);
- •According to the researcher's judgment, the subject / legal guardian is believed to be reliable and able to comply with this plan, visit plan and medication arrangement.
排除标准
- •Have a disease that needs to be distinguished from Mycoplasma pneumoniae pneumonia (MPP);
- •Patients with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, abnormal lung development, aspiration pneumonia, lung malignancies, etc .;
- •Congenital abnormalities of heart and lung, combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system, or any laboratory test indicators meet the following criteria: alanine aminotransferase (ALT), aspart Amino acid aminotransferase (AST)> 2.0 times, serum creatinine (Cr)> 1.5 times the upper limit of normal value (ULN);
- •Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months;
研究组 & 干预措施
Azithromycin plus Xiyanping injection group
干预措施: Azithromycin plus Xiyanping injection (Drug)
Azithromycin group
干预措施: Azithromycin (Drug)
结局指标
主要结局
Clinical recovery time
时间窗: up to day 19
Time from study drug use to complete fever and cough relief, measured in days
次要结局
未报告次要终点