Clinical trial NCT06325332: BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
Official title: BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiratory Syncytial Virus
Keywords: RSV
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 49680
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is an observational, retrospective cohort study designed to evaluate the effectiveness of nirsevimab to prevent RSV-confirmed respiratory-related medical encounters and health care utilization in infants entering their first RSV season compared to no treatment in the United States.

The source population is infants ≥ 37 weeks gestational age and aged 0 to 12 months (calendar age) entering their first RSV season and without significant medical history. There is also a high-risk infant population with infants \< 37 WGA and aged 0 to 12 months (calendar age), entering their first RSV season and infants ≥ 37 weeks with significant medical history diagnosed at birth up to the end of the observation period (ie, 30 April 2024). The study will aim to enroll approximately 33,000 infants.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)
timeFrame: Approximately 6 months
measure: Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Number of respiratory-related medical encounters
timeFrame: Approximately 6 months
measure: Number of respiratory-related medical encounters for LRTD by ICD-10 codes
timeFrame: Approximately 6 months
measure: Incidence of PCR-confirmed RSV (first occurrence of season)
timeFrame: Approximately 6 months
measure: Number of medical encounters for otitis media by ICD-10 codes
timeFrame: Approximately 6 months
measure: Number of antibiotic prescriptions by National Drug Code (NDC) codes
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California: Site number 0001
state: California
Study officials:
References: