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

Overview

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.

Full Title of Study: “A Randomized, Double-blind, Parallel-controlled,Multicenter Clinical Study of Xiyanping Injection Combined With Azithromycin and Azithromycin for Children With Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 15, 2021

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.

Interventions

  • 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
  • Drug: Azithromycin
    • Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d

Arms, Groups and Cohorts

  • Experimental: Azithromycin plus Xiyanping injection group
  • Active Comparator: Azithromycin group

Clinical Trial Outcome Measures

Primary Measures

  • Clinical recovery time
    • Time Frame: up to day 19
    • Time from study drug use to complete fever and cough relief, measured in days

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangxi Qingfeng Pharmaceutical Co. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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