Viral Pneumonia in Children
Conditions
Interventions
Test Group:To receive Peginterferon alfa-2b Injection (Pegabin?) administered by nebulization and inhalation at a dose of 90 µg per time, on Day 1, Day 3, and Day 5, concurrently with symptomatic and
Control group:Received ongoing symptomatic and supportive treatment
Sponsors
Shanxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1.Age: 1 year <= Age <= 5 years; 2.Gender: Both males and females are eligible; 3.Diagnosis: In accordance with the *Management Guidelines for Community-Acquired Pneumonia in Children (2024 Revision)*, subjects must meet criterion a and at least two of criteria b through d: (1) Laboratory Findings: Positive virological test results (excluding positive tests for influenza virus); (2). Clinical Symptoms: Onset of new cough, sputum production, or worsening of existing respiratory disease symptoms, accompanied by fever, tachypnea, or wheezing; (3). Physical Signs: Presence of fixed moist rales and/or signs of pulmonary consolidation; (4). Chest Imaging: New-onset patchy infiltrates, lobar or segmental consolidation, ground-glass opacities, or interstitial changes, with or without pleural effusion. 4.Timeframe: The time from the onset of illness (defined by the first appearance of fever, cough, wheezing, or any other symptom related to viral pneumonia) to the signing of the informed consent form is within 72 hours; 5.Informed Consent: The subject’s legal guardian understands the trial and has signed the informed consent form. (If the legal guardians are both parents, signatures from both are required).
Exclusion criteria
Exclusion criteria: 1. Presence of any of the following clinical signs and symptoms prior to enrollment: (1). General condition: Poor; (2). Food refusal or signs of dehydration: Present; (3). Consciousness disorder: Present; (4). Respiratory rate: Significantly increased (infants >=70 times/min, older children >=50 times/min); (5). Cyanosis: Present; (6). Dyspnea: Present; (7). Oxygen saturation: =2/3 of unilateral lung; (9). Pleural effusion: Present; (10). Extrapulmonary complications: Present. 2. Allergy and treatment history: (1). Use of antiviral drugs such as interferon, ribavirin, acyclovir, ganciclovir, or vidarabine within 30 days prior to screening or currently receiving such treatment; (2). Use of immunoglobulin therapy within 30 days prior to screening or currently receiving such treatment; (3). Known history of allergic reaction to interferon or its components, or any other clear history of allergy that makes the subject unsuitable for participation in this study; (4). Use of other investigational drugs within 3 months prior to screening or within 5 half-lives (whichever is longer), or participation in a medical device clinical trial at the time of screening. 3. Medical history and current medical conditions: (1). Current evidence of clear mixed bacterial infection; (2). History of congenital heart disease, severe malnutrition, immune system dysfunction, or other serious diseases of major organ systems; (3). History of HBV, HCV, HIV, or other viral infections; (4). History of malignant tumors (past or current); (5). History of epilepsy, or neurological/psychiatric disorders and family history thereof. 4. Other conditions: Subjects deemed by the investigator to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of fever;Time to resolution of cough;Time to resolution of rapid breathing;Time to resolution of wheezing;Time to resolution of pulmonary rales; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the difference in the proportion of subjects with alleviated/resolved fever between the two groups;Comparison of the difference in the proportion of subjects with alleviated/resolved cough between the two groups.;Comparison of the difference in the proportion of subjects with alleviated/resolved rapid breathing between the two groups.;Comparison of the difference in the proportion of subjects with alleviated/resolved wheezing between the two groups.;Comparison of the difference in the proportion of subjects with alleviated/resolved pulmonary rales between the two groups.;Comparison of the difference in time-to-recovery curves for fever between the two groups;Comparison of the difference in time-to-recovery curves for cough between the two groups;Comparison of the difference in time-to-recovery curves for rapid breathing between the two groups;Comparison of the difference in time-to-recovery curves for wheezing between the two groups;Comparison of the difference in time-to-recovery curves for pulmonary rales between the two groups;Comparison of the difference in total hospitalization time between the two groups;Comparison of the proportion of subjects who progress to severe pneumonia between the two groups; | — |
Countries
China
Contacts
Public ContactLi Jing
Shanxi Provincial People's Hospital
Outcome results
None listed