NCT04296383

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-08-15
• Completion: 2022-08-15
• First posted: 2020-03-05
• Last updated: 2020-05-19