BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Other: Nirsevimab
- Registration Number
- NCT06325332
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.
the secondary objectives are:
1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
3. To estimate the impact of nirsevimab on PCR-confirmed RSV.
4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
5. To estimate the impact of nirsevimab on antibiotic prescription.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 49680
- The Kaiser Permanente Northern California, USA (KPNC) member born on or after 01 April 2023 for Cohort 1 and Cohort 2.
- Eligible to receive nirsevimab as defined by the product indication.
- KPNC infants entering their first RSV season.
- Mother was administered an RSV vaccine during her pregnancy with the infant participant.
- Mother of infant participant was not a KPNC member during pregnancy.
- Mother did not deliver the infant participant at a KPNC facility.
- Infant receipt of other RSV pre-exposure prophylaxis (ie, Palivizumab).
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1: Nirsevimab-Exposed Cohort Nirsevimab Full-term (born ≥ 37 weeks gestational age) infants born on or after 01 April 2023, without a high-risk condition, who receive nirsevimab before or during their first RSV season per recommendations, ie, before or during the 2023-2024 RSV season.
- Primary Outcome Measures
Name Time Method Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) Approximately 6 months Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) diagnosis identified using International Classification of Diseases, Tenth Revision (ICD)
Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis Approximately 6 months Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis identified using ICD-10 codes: outpatient (OP) visits, emergency department (ED) visits, inpatient (IP) hospitalizations or intensive care unit (ICU) hospitalizations.
- Secondary Outcome Measures
Name Time Method Number of respiratory-related medical encounters Approximately 6 months Number of respiratory-related medical encounters (ie, Outpatient visits, Emergency department visits, In patient hospitalizations, and Intensive care unit hospitalizations) by ICD-10 codes.
Number of respiratory-related medical encounters for LRTD by ICD-10 codes Approximately 6 months Number of respiratory-related medical encounters for LRTD by ICD-10 codes.
Incidence of PCR-confirmed RSV (first occurrence of season) Approximately 6 months Incidence of PCR-confirmed RSV (first occurrence of season).
Number of medical encounters for otitis media by ICD-10 codes Approximately 6 months Number of medical encounters for otitis media by ICD-10 codes.
Number of antibiotic prescriptions by National Drug Code (NDC) codes Approximately 6 months Number of antibiotic prescriptions by NDC codes.
Trial Locations
- Locations (1)
Kaiser Permanente Northern California: Site number 0001
🇺🇸Oakland, California, United States