Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

NCT ID: NCT06030505

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2023-12-29

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 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.

Conditions

Bronchiolitis, Viral

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case patients

Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research.

No intervention required by the protocol

Intervention Type: OTHER

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.

Control patients

Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research.

No intervention required by the protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bondy - Jean Verdier

Bondy, , France

CHI Créteil

Créteil, , France

Hôpital Armand Trousseau AP-HP

Paris, , France

CHU Robert-Debré

Paris, , France

CHU Toulouse-hôpital des Enfants

Toulouse, , France

Countries

France

References

Assad Z, Romain AS, Aupiais C, Shum M, Schrimpf C, Lorrot M, Corvol H, Prevost B, Ferrandiz C, Giolito A, Valtuille Z, Bendavid M, Cohen JF, Toubiana J, de Pontual L, Delande CF, Levy M, See P, Cohen R, Levy C, Angoulvant F, Lenglart L, Gits-Muselli M, Biran V, Diallo K, Alemede O, El Hebil MM, Durrmeyer X, Labouret G, Casanovas N, Hallak B, Marechal O, Jung C, Brehin C, Ouldali N. Nirsevimab and Hospitalization for RSV Bronchiolitis. N Engl J Med. 2024 Jul 11;391(2):144-154. doi: 10.1056/NEJMoa2314885.

Reference Type: DERIVED

PMID: 38986058 (View on PubMed)

Other Identifiers

2023-A01803-42

Identifier Type: OTHER

Identifier Source: secondary_id

ENVIE

Identifier Type: -

Identifier Source: org_study_id