Peginterferon α-2b Injection for Aerosol Therapy in Pediatric Respiratory Syncytial Virus Pneumonia

Launched by WEST CHINA SECOND UNIVERSITY HOSPITAL · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for children with respiratory syncytial virus (RSV) pneumonia, a common lung infection that can cause serious breathing problems. The researchers want to find out if using a medication called Peginterferon α-2b as an aerosol (a mist that can be inhaled) is safe and effective for young children. The trial will involve children aged 1 to 3 years who test positive for RSV and show symptoms like fever, cough, and wheezing. To participate, children must be enrolled within 72 hours of showing symptoms and have their legal guardians provide consent.

Participants in the trial will be randomly assigned to receive either the Peginterferon treatment or a control treatment, and they will be monitored closely throughout the study. The trial is currently recruiting eligible children, and families can expect to engage in a screening period, a treatment phase, and a follow-up period to assess their child’s health. It’s important to note that children with certain serious health conditions or allergies may not be eligible to participate. The goal is to gather important information that could help improve treatment options for RSV pneumonia in young children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1)Age: 1 year ≤ age ≤ 3 years; (2) Gender: Both male and female participants are eligible; (3) According to the 9th edition of "Zhu Fute's Practical Pediatrics," meet the following diagnostic criteria: a. RSV test positive; b. Clinical manifestations: Fever, cough, wheezing; c. Physical signs: Rapid breathing and moist rales in the lungs; (4) Time: The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (starting from the occurrence of any symptom such as fever, cough, or wheezing); (5) Informed consent: The legal guardian of the child understands and signs the informed consent form (if the legal guardians are the parents, both parents need to sign together).
• Exclusion Criteria:
• • (1) Presence of any of the following clinical symptoms before enrollment: a. Poor general condition, with altered consciousness, refusal to eat, or signs of dehydration; b. Hypoxemia: Presence of cyanosis, rapid breathing (RR ≥ 50 breaths per minute), stridor, nasal flaring, tracheal tug, oxygen saturation \< 92%, and intermittent apnea; c. Extrapulmonary complications; d. Chest X-ray or CT: Multilobar lung infiltrates, pleural effusion, pneumothorax, atelectasis, lung necrosis, and lung abscess; e. Hyperpyrexia: Persistent high fever for more than 5 days; f. Presence of critical complications such as respiratory failure and circulatory failure; (2) Allergy history and treatment history: a. Receiving antiviral drug treatment with interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days before screening or currently; b. Receiving immunoglobulin treatment within 30 days before screening or currently; c. Known hypersensitivity to interferon or its components, or a clear history of other allergies that make participation in this study inappropriate; d. Use of other investigational drugs within 3 months before screening or within 5 half-lives (whichever is longer), or currently participating in a clinical trial for a medical device at the time of screening; (3) Disease history and current medical history: a. History of congenital heart disease, severe malnutrition, abnormal immune system function, or other serious diseases of major organ systems; b. Severe liver or renal dysfunction; c. History of viral infections such as HBV, HCV, HIV; d. Past or current history of malignant tumors; e. Past history of epilepsy, or history and family history of neurological/psychiatric disorders; (4) Other conditions: Subjects deemed unsuitable for participation in this trial by the investigator.