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A multicenter, randomized, controlled clinical study on the efficacy and safety of aerosol inhalation of interferon a2b for children with adenovirus pneumonia

A multicenter, randomized, controlled clinical study on the efficacy and safety of aerosol inhalation of interferon a2b for children with adenovirus pneumonia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054534
Enrollment
Unknown
Registered
2021-12-19
Start date
2021-12-18
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenovirus pneumonia

Interventions

Experimental group:Atomization inhalation of interferon a2b
Control group:Atomization inhalation of normal saline

Sponsors

Kunming Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 4 Years

Inclusion criteria

Inclusion criteria: 1. Aged 3 months to 4 years, male or female; 2. Those with onset within 72 hours; 3. The clinical diagnosis is common adenovirus pneumonia, and the diagnostic criteria are in accordance with the "Guidelines for the Diagnosis and Treatment of Adenovirus Pneumonia in Children (2019 Edition)"; 4. Adenovirus test positive (any one of the following positive is diagnosed as adenovirus infection): (1) Fluorescence PCR method or immunofluorescence method detects positive for adenovirus in sputum and (or) bronchoalveolar lavage fluid; (2) Serum adenovirus-IgM positive. 5. No other antiviral drugs and immunomodulatory preparations were used within one week before diagnosis and treatment.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to interferon; 2. Patients with systemic lupus erythematosus, psoriasis and other autoimmune diseases or immunodeficiency diseases; 3. Patients with severe basic diseases, including congenital heart disease, plastic bronchitis, bronchopulmonary dysplasia, liver and kidney dysfunction and severe malnutrition; 4. Patients with epilepsy or other central nervous system disorders; 5. Patients with HBV, HCV, HIV, EBV and other viral infection; 6. Patients with mixed bacteria, mold or mycoplasma infection before enrollment; 7. Refusing to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Effective rate;Virologic response rate;

Secondary

MeasureTime frame
Length of hospitalization;Fever clearance time;Time to disappearance of pulmonary rales;Time to coughing disappearance;Time for breathing to return to normal;Time for heart rate to return to normal;Serum TNFa;Serum IFN?;Serum IL-2;Serum IL-4;Serum IL-6;Serum IL-10;Serum IL-17A;Serum procalcitonin;Serum C-reactive protein;Chest X-ray;

Countries

China

Contacts

Public ContactFu Hongmin

Kunming Children's Hospital

510844660@qq.com+86 15198910315

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026