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

NCT04158310 | Unknown

• 1 other identifier: QF-XYP1908-2
• Study Type: observational
• Target: 9,207
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 8, 2019
• Study Start: November 11, 2019
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: November 8, 2019

Record last verified: 2019-10