Mycoplasma Pneumoniae Pneumonia Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-controlled,Multicenter Clinical Study of Xiyanping Injection Combined With Azithromycin and Azithromycin for Children With Pneumonia
Verified date | May 2020 |
Source | Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | August 15, 2022 |
Est. primary completion date | August 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 14 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical recovery time | Time from study drug use to complete fever and cough relief, measured in days | up to day 19 |
Status | Clinical Trial | Phase | |
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