A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Duration of Fever
研究概览
简要总结
This is a multicenter, randomized, open Label, add-on study.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Oseltamivir Phosphate+Xiyanping injection
Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days
干预措施: Xiyanping injection+Oseltamivir Phosphate (Drug)
Oseltamivir Phosphate treatment only
Oseltamivir Phosphate treatment for 7-10 days
干预措施: Oseltamivir Phosphate (Drug)
结局指标
主要结局
Duration of Fever
时间窗: Up to Day 12
Length of time taken by participants to return to afebrile state
Time to Alleviation of Influenza Signs and Symptoms
时间窗: Up to Day 12
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.
次要结局
- Imaging improvement rate: number of people with normal or baseline imaging(Up to Day 12)
- Signs and Symptoms Score from baseline(Up to Day 12)
- Relief time of individual symptom such as:expectoration, cough(Up to Day 12)
- Usage of antibiotic,hormone and incidence of critical cases(Up to Day 12)
- Time to Cessation of Viral Shedding by RT-PCR(Up to Day 12)
- Disease efficacy criteria(Up to Day 12)