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New treatment option for Bronchiolitis
Official title Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
ClinicalTrials.gov ID: NCT06827249
What this study is testing
What is Peginterferon α-2b injection?
Peginterferon α-2b injection is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for bronchiolitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 2
You may be able to join if
- The guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse...
- 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...
- 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...
- The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- No use of other antiviral drugs or immunomodulators within 3 weeks before randomization.
- 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 treatment 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Suzhou, Jiangsu, China; Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.