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Search / Trial NCT06030505

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

Launched by CENTRE HOSPITALIER INTERCOMMUNAL CRETEIL · Sep 1, 2023

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called nirsevimab in children who are hospitalized due to a condition called RSV bronchiolitis. RSV, or respiratory syncytial virus, is a common virus that can cause serious respiratory infections in young children, leading to many emergency room visits and hospital stays each year. Nirsevimab is a monoclonal antibody designed to help the body fight off RSV more effectively, and this trial will help determine how well it works and how safe it is for infants under 12 months of age who have been treated for this condition.

To participate in the trial, children must be under 12 months old and have been hospitalized for acute RSV bronchiolitis. There are also control participants who may have been hospitalized for other reasons but do not have RSV or respiratory symptoms. Families considering participation can expect close monitoring and care throughout the study. It's important to know that children who have received certain other RSV treatments or vaccinations will not be eligible to join the trial. This research aims to improve how we manage and prevent RSV infections in young children, potentially leading to better health outcomes for many families.

Gender

ALL

Eligibility criteria

  • 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.

About Centre Hospitalier Intercommunal Creteil

Centre Hospitalier Intercommunal Créteil (CHIC) is a leading healthcare institution in the Val-de-Marne department of France, dedicated to delivering high-quality medical care and advancing clinical research. As a prominent clinical trial sponsor, CHIC collaborates with healthcare professionals and academic institutions to facilitate innovative research initiatives aimed at improving patient outcomes. The center is committed to adhering to rigorous ethical standards and regulatory guidelines, ensuring the safety and efficacy of interventions tested within its clinical trials. CHIC’s multidisciplinary approach fosters an environment of collaboration and excellence, positioning it as a key player in the advancement of medical knowledge and therapeutic options.

Locations

Créteil, , France

Paris, , France

Toulouse, , France

Paris, , France

Bondy, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported