Actively Recruiting
Peginterferon Alpha-2b Injection for Aerosol Therapy in Children Aged 1 to 3 Years With Respiratory Syncytial Virus Pneumonia
Led by West China Second University Hospital · Updated on 2025-03-18
90
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of aerosolized Peginterferon alpha-2b injection for treating children aged 1 to 3 years with respiratory syncytial virus (RSV) pneumonia. This multicenter, randomized, open-label, parallel-controlled clinical study aims to compare two doses of Peginterferon alpha-2b with standard care to better understand its potential benefits in this young population. Participants will be randomly assigned to one of three groups: a 45 mcg dose Peginterferon alpha-2b group, a 90 mcg dose Peginterferon alpha-2b group, or a control group receiving only symptomatic and supportive treatment. The medication is given by nebulization on the 1st, 3rd, and 5th days. The study includes a screening period, a treatment period, and a follow-up period to monitor participants' progress and response. During the study, children will be closely monitored for improvement in major clinical symptoms like fever, cough, and wheezing, as well as physical signs such as rapid breathing and lung sounds. The main outcomes measured include the time until these symptoms and signs disappear, assessed by day 6. Researchers will also compare treatment efficacy rates, symptom relief at days 3 and 5, and total hospitalization duration among groups. Safety and response will be regularly evaluated throughout the study and follow-up phases.
CONDITIONS
Brief Title
Peginterferon α-2b Injection for Aerosol Therapy in Pediatric Respiratory Syncytial Virus Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 3 years
- Both male and female children are eligible
- Positive test for respiratory syncytial virus (RSV)
- Clinical symptoms including fever, cough, and wheezing
- Physical signs such as rapid breathing and moist lung sounds
- Onset of illness symptoms within 72 hours before consent
- Legal guardian(s) must provide informed consent
You will not qualify if you...
- Poor general condition with altered consciousness, refusal to eat, or dehydration
- Low oxygen levels or breathing difficulties including cyanosis and apnea
- Presence of complications outside the lungs
- Lung imaging showing multilobar infiltrates, effusion, pneumothorax, atelectasis, necrosis, or abscess
- High fever lasting more than 5 days
- Critical complications like respiratory or circulatory failure
- Recent or current antiviral or immunoglobulin treatments
- Known allergies to interferon or study components
- Participation in other investigational drug or device trials recently
- History of congenital heart disease, severe malnutrition, immune disorders, or major organ diseases
- Severe liver or kidney dysfunction
- Viral infections including HBV, HCV, or HIV
- History of cancer or neurological/psychiatric disorders
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive peginterferon α-2b injections by aerosol therapy on the 1st, 3rd, and 5th day while also receiving symptomatic and supportive treatment.
3 visits (in-person) on Days 1, 3, and 5
Trial Site Locations
Total: 2 locations
1
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Actively Recruiting
2
West China Second University Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
L
Lina Chen, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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