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

NCT ID: NCT03947411

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2020-03-31

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.

Conditions

Severe Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oseltamivir Phosphate+Xiyanping injection

Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days

Group Type: EXPERIMENTAL

Xiyanping injection+Oseltamivir Phosphate

Intervention Type: DRUG

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.

Oseltamivir Phosphate treatment only

Oseltamivir Phosphate treatment for 7-10 days

Group Type: ACTIVE_COMPARATOR

Oseltamivir Phosphate

Intervention Type: DRUG

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

Interventions

Oseltamivir Phosphate

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

Xiyanping injection+Oseltamivir Phosphate

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Beijing Luhe Hospital

OTHER

Sponsor Role: collaborator

Qingdao Municipal Hospital

OTHER

Sponsor Role: collaborator

Cangzhou People's Hospital

OTHER

Sponsor Role: collaborator

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xilian Zhang

Role: CONTACT

yfyiec@163.com

022-27432299

Facility Contacts

Xilian Zhang

Role: primary

yfyiec@163.com

022-27432299

Other Identifiers

JXQF- XYP-1801

Identifier Type: -

Identifier Source: org_study_id