Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325332
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-15
Brief Title:
BEYFORTUS Nirsevimab Effectiveness Against Medically-Attended RSV Events in Infants BEAR Study
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
BEYFORTUS Nirsevimab Effectiveness Against Medically-Attended RSV Events in Infants BEAR Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAR
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None