跳至主要内容
临床试验/NCT04158310
NCT04158310Unknown不适用

Evaluation of Clinical Value and Safety of Xiyanping Injection in the Treatment of Community-acquired Pneumonia in Children Based on Real-world Clinical Data

Jiangxi Qingfeng Pharmaceutical Co. Ltd.0 个研究点目标入组 9,207 人开始时间: 2019年11月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
9,207
主要终点
Time to Alleviation of Cough and Lung X-ray

研究概览

简要总结

In order to verify the clinical value and safety of Xiyanping injection in children with CAP, we intend to carry out this multi-center, large-sample, non-intervention clinical research through more rigorous and scientific design. Considering the current status of clinical research in children in China,research use real-world research methods.

详细描述

This is an real world study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with CAP.The purpose to determine the clinical value and influencing factors of Xiyanping injection in the treatment of community-acquired pneumonia in children based on real-world clinical data. The starting point for the study was the time at which the patient started treatment with Xiyanping injection or using a conventional treatment regimen; the end of follow-up was the date of the last visit to the patient, and if the patient had a disease progression or transfer, the date of the occurrence was the end. At the same time, baseline demographic characteristics (gender, date of birth, type of medical insurance, etc.), therapeutic drugs during the follow-up period, dose and time of use, laboratory indicators (such as white blood cells, C-reactive protein, etc., and examination time) were collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Time to Alleviation of Cough and Lung X-ray

时间窗: 7 days

significant efficiency: cough and lung X-ray show obvious improvement of symptoms within 3 days; effective: cough and lung X-ray symptoms improve within 3 to 7 days; invalid: no change or aggravation of lung symptoms after 7 days' treatment. Total effective rate = significant efficiency rate + effective rate

Time to Alleviation of Body Temperature

时间窗: 7 days

significant efficiency: body temperature return to normal within 3 days; effective: body temperature return to normal within 3 to 7 days; invalid: body temperature can't return to normal after 7 days' treatment. Total effective rate = significant efficiency rate + effective rate

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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