Status:
COMPLETED
Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Conditions:
Bronchiolitis, Viral
Eligibility:
All Genders
Up to 1 years
Brief Summary
Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide burden and represent a major public health issue. In France, bronchiolitis is responsible for around 100,000 em...
Eligibility Criteria
Inclusion
- Cases :
- Children under 12 months of age
- Treated for acute RSV bronchiolitis
- Hospitalised following a visit to the paediatric emergency department
- Controls :
- Children under 12 months
- Hospitalised in the conventional sector or in a short-stay hospital unit, or having consulted a paediatric emergency department for one of the following reasons
- Febrile urinary tract infection, without acute ear, nose, and throat (ENT) or respiratory symptoms
- Acute gastroenteritis, without acute ENT or respiratory symptoms
- Infant colic without fever, without ENT or acute respiratory symptoms
- Stagnant weight or feeding difficulties without fever, acute ENT or respiratory symptoms
- Neonatal jaundice without fever or acute ENT or respiratory symptoms
- Unexplained crying without fever, without ENT or acute respiratory symptoms
- Head injury, without acute ENT or respiratory symptoms
- Patient hospitalised for acute surgery without fever, without ENT or acute respiratory symptoms
Exclusion
- Refusal to participate by the patient, their relative or legal representative
- Administration of Palivizumab.
- Maternal vaccination against RSV.
Key Trial Info
Start Date :
October 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
1140 Patients enrolled
Trial Details
Trial ID
NCT06030505
Start Date
October 15 2023
End Date
December 29 2023
Last Update
August 29 2025
Active Locations (5)
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1
CHU Bondy - Jean Verdier
Bondy, France
2
CHI Créteil
Créteil, France
3
Hôpital Armand Trousseau AP-HP
Paris, France, 75012
4
CHU Robert-Debré
Paris, France