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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04296383
Other study ID # QF-XYP1908-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date August 15, 2022

Study information

Verified date May 2020
Source Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 provide more reasonable and standardized application guidance and basis for clinical practice, we intend to adopt more rigorous Scientific design to carry out a multi-center, randomized, double-blind, parallel-controlled study of Xiyanping injection in the treatment of children with Mycoplasma pneumoniae pneumonia.


Recruitment information / eligibility

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;

Study Design


Intervention

Drug:
Azithromycin plus Xiyanping injection
Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d;Xiyanping injection intravenously, 0.4mL / (kg.d) daily, Qd
Azithromycin
Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Outcome

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
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