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Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms

Primary Purpose

Severe Influenza

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Oseltamivir Phosphate

Xiyanping injection+Oseltamivir Phosphate

About this trial

This is an interventional treatment trial for Severe Influenza focused on measuring severe Influenza

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 3 and 6 years old;
Clinical diagnosis of Severe Influenza with hospital treatment needed;
Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;
（1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; （2）Combined pneumonia;
The rapid viral antigen test of throat swab and nose swab results were positive;
Guardians understood and assigned the informed consent;

Exclusion Criteria:

Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate;
Creatinine clearance <80ml/min or received continuous renal replacement therapy (CRRT) test;
Need extracorporeal membrane oxygenation (ECMO) at baseline;
Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline;
Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring;
Use of systemic steroids or other immunosuppressants;
Participants with the following underlying diseases, including: heart disease (such as New York Heart Function Classification II-IV) or clinically significant arrhythmia (such as QTc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( ALT and AST ≥ 1.5 × ULN; Cr and BUN > 1.2 × ULN), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc.
Participants used Influenza virus vaccine within 3 months;
Participants with drug dependence or with mental disorders within 1 year;
Participants participated in other clinical research in the last 30 days;
Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.

Sites / Locations

The First Affliated Hospital of Tianjin University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oseltamivir Phosphate+Xiyanping injection

Oseltamivir Phosphate treatment only

Arm Description

Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days

Oseltamivir Phosphate treatment for 7-10 days

Outcomes

Primary Outcome Measures

Time to Alleviation of Influenza Signs and Symptoms

Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.

Duration of Fever

Length of time taken by participants to return to afebrile state

Secondary Outcome Measures

Signs and Symptoms Score from baseline

(1) recovery: symptom score reduction rate ≥ 95%; (2) markedly effective: symptom score reduction rate ≥ 70%; (3) progress: symptom score reduction rate ≥ 30%; (4) invalid: Symptom score reduction rate <30%.

Usage of antibiotic,hormone and incidence of critical cases

Time to Cessation of Viral Shedding by RT-PCR

Relief time of individual symptom such as:expectoration, cough

Disease efficacy criteria

(1) Healing: The body temperature is normal within 48 hours of treatment, the symptoms disappeared without repetition. (2) markedly effective: the body temperature is normal within 48 hours of treatment, and the symptom score is reduced by more than 2/3. (3) Effective: The body temperature is normal within 72 hours of treatment, and the remaining symptom scores are reduced by 2/3-1/3. (4) Invalid: The condition did not improve or worsened after 72 hours of treatment.

Imaging improvement rate: number of people with normal or baseline imaging

Full Information

NCT ID

NCT03947411

First Posted

May 8, 2019

Last Updated

May 13, 2019

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Collaborators

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Beijing Luhe Hospital, Qingdao Municipal Hospital, Cangzhou People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03947411

Brief Title

Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms

Official Title

A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 4, 2019 (Actual)

Primary Completion Date

March 31, 2020 (Anticipated)

Study Completion Date

March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a multicenter, randomized, open Label, add-on study.

Detailed Description

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms. The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Influenza

Keywords

severe Influenza

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oseltamivir Phosphate+Xiyanping injection

Arm Type

Experimental

Arm Description

Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days

Arm Title

Oseltamivir Phosphate treatment only

Arm Type

Active Comparator

Arm Description

Oseltamivir Phosphate treatment for 7-10 days

Intervention Type

Drug

Intervention Name(s)

Oseltamivir Phosphate

Intervention Description

Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.

Intervention Type

Drug

Intervention Name(s)

Xiyanping injection+Oseltamivir Phosphate

Intervention Description

Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.

Primary Outcome Measure Information:

Title

Time to Alleviation of Influenza Signs and Symptoms

Description

Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.

Time Frame

Up to Day 12

Title

Duration of Fever

Description

Length of time taken by participants to return to afebrile state

Time Frame

Up to Day 12

Secondary Outcome Measure Information:

Title

Signs and Symptoms Score from baseline

Description

Time Frame

Up to Day 12

Title

Usage of antibiotic,hormone and incidence of critical cases

Time Frame

Up to Day 12

Title

Time to Cessation of Viral Shedding by RT-PCR

Time Frame

Up to Day 12

Title

Relief time of individual symptom such as:expectoration, cough

Time Frame

Up to Day 12

Title

Disease efficacy criteria

Description

Time Frame

Up to Day 12

Title

Imaging improvement rate: number of people with normal or baseline imaging

Time Frame

Up to Day 12

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

3 to 6 years old hospitalized patient

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 3 and 6 years old; Clinical diagnosis of Severe Influenza with hospital treatment needed; Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment; （1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; （2）Combined pneumonia; The rapid viral antigen test of throat swab and nose swab results were positive; Guardians understood and assigned the informed consent; Exclusion Criteria: Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate; Creatinine clearance <80ml/min or received continuous renal replacement therapy (CRRT) test; Need extracorporeal membrane oxygenation (ECMO) at baseline; Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline; Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring; Use of systemic steroids or other immunosuppressants; Participants with the following underlying diseases, including: heart disease (such as New York Heart Function Classification II-IV) or clinically significant arrhythmia (such as QTc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( ALT and AST ≥ 1.5 × ULN; Cr and BUN > 1.2 × ULN), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc. Participants used Influenza virus vaccine within 3 months; Participants with drug dependence or with mental disorders within 1 year; Participants participated in other clinical research in the last 30 days; Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xilian Zhang

Phone

022-27432299

yfyiec@163.com

Facility Information:

Facility Name

The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xilian Zhang

Phone

022-27432299

yfyiec@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms

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