A randomized, double-blind, parallel-controlled, multicenter trial to evaluate the effectiveness and safety of Xiyanping injection combined with azithromycin and azithromycin in the treatment of mycoplasma pneumoniae pneumonia in children

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Aged 5 to 14 years at the time of screening;
•2. Children who meet the Western medicine clinical diagnosis standard of Mycoplasma pneumoniae (Chinese hospitals also need to meet the Chinese medicine syndrome standard of wind-heat-closed-lung / phlegm-heat-closed-lung / toxic-heat-closed-lung syndrome), 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;
•3. Heat course <=5 days;
•4. The total number of peripheral blood routine leukocytes is within the normal range;
•5. 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);
•6. 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.

•1. Have diseases that need to be distinguished from Mycoplasma pneumoniae pneumonia (MPP), such as tuberculosis, bacterial or viral pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
•2. Patients with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, abnormal lung development, aspiration pneumonia, lung malignancies, etc .;
•3. Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months.

发起方

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine