Evaluation the Clinical Value of Xiyanping Injection in the Treatment of Community-acquired Pneumonia in Children

Community Acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04158310
• Other study ID #: QF-XYP1908-2
• Status: Not yet recruiting
• Start date: November 11, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: October 2019
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9207
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion criteria:

• 2 years old < age = 14 years old children, male or female, diagnosed as community-acquired pneumonia diagnosed and need hospitalization

Exclusion criteria:

• Acute infectious diseases such as measles, whooping cough, and influenza

• Other concomitant diseases or conditions that the investigators believe may interfere with the study, such as severe primary disease with severe heart, liver, kidney, digestive, and hematopoietic systems

• Children with severe malnutrition and previous history of immunodeficiency may seriously affect the self-limiting course of the disease

• Children with epilepsy and other central nervous system dysfunction

• Congenital diseases, mental patients

• Those who have used systemic hormones within 2 weeks before enrollment;

• Those who have used Qingrejiedu Chinese medicine within 2 weeks before enrollment

• The subject is poorly compliant (not according to the doctor's prescription or medical advice) or fails to timely feedback information

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Alleviation of Cough and Lung X-ray	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	7 days
Primary	Time to Alleviation of Body Temperature	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	7 days