NCT06827249招募中不适用
A Multicenter, Randomized, Positive-controlled, Non-inferiority Clinical Study to Evaluate the Safety and Efficacy of Peginterferon α2b Injection in the Treatment of Pediatric RSV Bronchiolitis
Children's Hospital of Soochow University3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- The rate of change in Wang's bronchiolitis score from baseline.
研究概览
简要总结
This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse reactions that may occur during the study, is willing to complete the follow-up as required, and voluntarily signs the informed consent form before the start of the study.
- •The child's age is 6 months or older but no more than 2 years old (including the critical value) at the time of signing the informed consent, and the gender is not specified.
- •Positive viral detection in nasopharyngeal swab.
- •Presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in the lungs; with or without chest imaging showing signs of hyperinflation, patchy infiltrates, localized atelectasis, and peribronchitis.
- •The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
- •The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (the appearance of symptoms and signs related to RSV bronchiolitis does not exceed 72 hours from the signing of the informed consent, including but not limited to: tachypnea, wheezing, hypoxemia, dyspnea, fever).
- •No use of other antiviral drugs or immunomodulators within 3 weeks before randomization.
排除标准
- •Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing.
- •Presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.
- •Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases.
- •Having epilepsy or other disorders of central nervous system function.
- •The investigator's comprehensive judgment suspects a concurrent bacterial infection.
- •Clinical diagnosis of myocarditis or suspected myocarditis (diagnostic criteria see Appendix 2: Diagnostic Recommendations for Myocarditis in Children).
- •Known or suspected allergy to interferon or excipients.
- •Participation in other interventional clinical trials within 3 months prior to screening, or planning to participate in other clinical trials during the study period. (9) A history of pneumonia in the past 3 months.
- •(10) Other conditions deemed unsuitable for inclusion by the investigator.
研究组 & 干预措施
Peginterferon α-2b 90 mcg dose group
Experimental
The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment.
干预措施: Peginterferon α-2b injection (Drug)
Recombinant human interferon α-2b dose group
Active Comparator
The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b.
干预措施: Recombinant Human Interferon α2b (Drug)
结局指标
主要结局
The rate of change in Wang's bronchiolitis score from baseline.
时间窗: Day 6.
次要结局
- Adverse Event(AE).(through study completion, an average of 18 months)
- Wang's bronchiolitis score change from baseline.(Day1-7.)
- The proportion of Wang's bronchiolitis score being 0 points.(Day6.)
- Length of hospital stay.(through study completion, an average of 18 months)
- Duration of oxygen therapy support.(through study completion, an average of 18 months)
- Change in viral load from baseline.(through study completion, an average of 18 months)
- Body temperature.(through study completion, an average of 18 months)
- Number of Participants with Abnormal Laboratory Parameters Findings.(through study completion, an average of 18 months)
- The number of research subjects who withdrew early.(through study completion, an average of 18 months)
研究者
Hao Chuangli
Chief physician
Children's Hospital of Soochow University
研究点 (3)
Loading locations...
相似试验
已完成
不适用
A Randomized, Controlled, Multi-Center, Non-Inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with/without Leg Paiower Back PainLeg PainLower Back PainNeurological - Other neurological disordersMusculoskeletal - Other muscular and skeletal disordersACTRN12620000939998Presidio Medical AU, Pty Ltd91
进行中（未招募）
1 期
Clinical Study to Evaluate the Effectiveness and Safety of NTC chondrograft® versus the Standard Procedure Arthroscopic Microfracture as the Standard Procedure in the Treatment of Symptomatic Articular Cartilage Defects of the KneeSymptomatic knee articular cartilage defectsEUCTR2017-002601-35-CZPrimeCell Advanced Therapy a.s.214
招募中
不适用
Atrial Sensing Capability for Better Detection of Atrial FibrillatioInjury, poisoning and certain other consequences of external causesKCT0003893Samsung Medical Center280
已完成
2 期
Clinical Study of Dabur Hepano tablet in comparison with a marketed Hepatoprotective formulation in Liver Disorder PatientsCTRI/2014/02/004410Dabur India Limited180
已完成
不适用
A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema.COPD emphysema10038716NL-OMON41236Pulmonx International Sarl25