Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

Last updated: April 18, 2024
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

No intervention required by the protocol

Clinical Study ID

NCT06030505
ENVIE
2023-A01803-42
  • Ages < 1
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 havingconsulted a paediatric emergency department for one of the following reasons
  • Febrile urinary tract infection, without acute ear, nose, and throat (ENT) orrespiratory 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 respiratorysymptoms
  • 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 respiratorysymptoms

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 963
Treatment Group(s): 1
Primary Treatment: No intervention required by the protocol
Phase:
Study Start date:
October 17, 2023
Estimated Completion Date:
July 15, 2026

Connect with a study center

  • CHU Bondy - Jean Verdier

    Bondy,
    France

    Active - Recruiting

  • CHI Créteil

    Créteil,
    France

    Active - Recruiting

  • CHU Robert-Debré

    Paris,
    France

    Active - Recruiting

  • Hôpital Armand Trousseau AP-HP

    Paris, 75012
    France

    Active - Recruiting

  • CHU Toulouse-hôpital des Enfants

    Toulouse,
    France

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.