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

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

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.

Study Overview

• Status: Unknown
• Conditions: Community Acquired Pneumonia

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 9207

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard treatment only; Standard treatment only such as antiasthmatic, expectorant and antipyretic
Standard treatment+Xiyanping injection; Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 11, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (ACTUAL): November 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: QF-XYP1908-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No