Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

Bronchiolitis, Viral Clinical Trial

— ENVIE  

Official title:

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030505
• Other study ID #: ENVIE
• Secondary ID: 2023-A01803-42
• Status: Recruiting
• Start date: October 17, 2023
• Est. completion date: July 15, 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Camille JUNG
• Phone: 0145175000
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 emergency room visits and 50,000 hospital admissions every year; 75% of infants hospitalised for RSV bronchiolitis are healthy full-term children. Recent discoveries concerning the specific viral epitopes of RSV have made it possible to move from an empirical approach to a targeted preventive or curative approach (monoclonal antibodies, vaccines, anti-viral drugs). Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV requiring medical management in healthy premature and term infants, with a favourable safety profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3, 2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European Medicines Agency (EMA) on November 4, 2022.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 963
• Est. completion date: July 15, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

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 Criteria:

• Refusal to participate by the patient, their relative or legal representative
• Administration of Palivizumab.
• Maternal vaccination against RSV.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Other:
• No intervention required by the protocol
No visits or samples will be taken specifically for this study. This research involves only prospective or retrospective data collection in relation to the usual hospital management of the child included. Similarly, patient follow-up will be strictly within the framework of their usual hospital care in relation to their pathology.

Locations

Country	Name	City	State
France	CHU Bondy - Jean Verdier	Bondy
France	CHI Créteil	Créteil
France	CHU Robert-Debré	Paris
France	Hôpital Armand Trousseau AP-HP	Paris
France	CHU Toulouse-hôpital des Enfants	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients passively immunised with nirsevimab	Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group	7 days
Secondary	Proportion of hospitalised children for RSV bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab	Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis requiring invasive or non-invasive ventilatory support, including RSV bronchiolitis	7 days
Secondary	Length of hospital stay	Length of hospital stay for children with RSV bronchiolitis.	7 days
Secondary	Time immunisation	Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.	7 days
Secondary	Frequency of hospital admissions	Monthly frequency of hospital admissions for RSV bronchiolitis among participating centres over time	7 days
Secondary	Proportion of children hospitalised for RSV bronchiolitis with viral co-detection	Proportion of children hospitalised for RSV bronchiolitis with viral co-detection or viral detection other than RSV on nasopharyngeal swab	7 days