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

NCT ID: NCT04296383

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-08-15

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.

Conditions

Mycoplasma Pneumoniae Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Azithromycin plus Xiyanping injection group

Group Type: EXPERIMENTAL

Azithromycin plus Xiyanping injection

Intervention Type: DRUG

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 group

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Azithromycin

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

QF-XYP1908-1

Identifier Type: -

Identifier Source: org_study_id