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

November 6, 2019 updated by: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Alleviation of Cough and Lung X-ray
Time Frame: 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
7 days
Time to Alleviation of Body Temperature
Time Frame: 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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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