Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia

• Status: Not yet recruiting
• Trial end date: 2022-08-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

1. 5 to 14 years of age at the time of screening;

2. 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;

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.

Exclusion Criteria:

1. Have a disease that needs to be distinguished from Mycoplasma pneumoniae pneumonia (MPP);

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. 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);

4. Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months;