Status:
UNKNOWN
Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia
Lead Sponsor:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Conditions:
Mycoplasma Pneumoniae Pneumonia
Eligibility:
All Genders
5-14 years
Phase:
NA
Brief 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.
Detailed Description
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2022
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04296383
Start Date
June 15 2020
End Date
August 15 2022
Last Update
May 19 2020
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