Lower Respiratory Tract Infections, RSV Infections
Conditions
Brief summary
A multicenter, retrospective cohort study based on clinical data from seven tertiary hospitals in China will be undertaken. The study aims to evaluate the real-world effectiveness of Nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections and all-cause respiratory infections. Clinical records will be used to compare outcomes between infants who received Nirsevimab and a control group. The study focuses on infants aged 0 to 1 year during the RSV season.
Detailed description
The purpose of this study is to evaluate the effectiveness of Nirsevimab in preventing RSV-related and all-cause lower respiratory tract infections (LRTI) among infants in a real-world setting. The target population includes infants aged 0 to 1 year enrolled across seven Chinese tertiary hospitals during the RSV season (September 2024 through April 2025). The study employs a target trial emulation design to compare infants receiving Nirsevimab with a control group of infants who did not receive Nirsevimab. Outcomes will be assessed over a follow-up period of up to 180 days. Researchers will utilize hospital electronic medical records to identify the incidence of infections, hospitalizations, and admissions to the intensive care unit (ICU). Statistical methods, such as inverse probability of treatment weighting, will be applied to balance the characteristics of the two groups and ensure a valid comparison.
Interventions
BIOLOGICALNirsevimab
Nirsevimab will be administered as a single intramuscular dose of 50 mg for infants \< 5 kg and 100 mg for infants ≥ 5 kg.
Sponsors
Han Tongyan
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
Inclusion criteria
Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
Exclusion criteria
1. Prior or active RSV infection. 2. Prior RSV immunization (maternal vaccine or monoclonal antibody).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of RSV-related LRTI hospitalization. | From enrollment up to 180 days. | Number of participants admitted to the hospital (inpatient care) with a diagnosis of LRTI and a laboratory-confirmed RSV infection (detected by PCR or antigen testing). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause LRTI hospitalization. | From enrollment up to 180 days. | Number of participants admitted to the hospital with a diagnosis of LRTI caused by any pathogen (including RSV, other viruses, or bacteria) or unspecified agents. |
Countries
China
Outcome results
None listed