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

450 participantsStarted 2020-06-15

Plain-language 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.

Who can participate

Age range5 Years – 14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Clinical recovery time

Timeframe: up to day 19

Trial details

NCT IDNCT04296383

SponsorJiangxi Qingfeng Pharmaceutical Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-15

View on ClinicalTrials.gov More Mycoplasma Pneumoniae Pneumonia trials