Back to resultsXiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia
Primary Purpose
Mycoplasma Pneumoniae Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Azithromycin plus Xiyanping injection
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Mycoplasma Pneumoniae Pneumonia
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Azithromycin plus Xiyanping injection group
Azithromycin group
Arm Description
Outcomes
Primary Outcome Measures
Clinical recovery time
Time from study drug use to complete fever and cough relief, measured in days
Secondary Outcome Measures
Full Information
NCT ID
NCT04296383
First Posted
March 3, 2020
Last Updated
May 17, 2020
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04296383
Brief Title
Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia
Official Title
A Randomized, Double-blind, Parallel-controlled,Multicenter Clinical Study of Xiyanping Injection Combined With Azithromycin and Azithromycin for Children With Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoplasma Pneumoniae Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin plus Xiyanping injection group
Arm Type
Experimental
Arm Title
Azithromycin group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Azithromycin plus Xiyanping injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d
Primary Outcome Measure Information:
Title
Clinical recovery time
Description
Time from study drug use to complete fever and cough relief, measured in days
Time Frame
up to day 19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
12. IPD Sharing Statement
Learn more about this trial
Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia
We'll reach out to this number within 24 hrs