Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

NCT06030505 | Completed

• 2 other identifiers: ENVIE2023-A01803-42
• Study Type: observational
• Target: 1,140
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of hospitalised children for RSV bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab

  7 days

• Length of hospital stay

  7 days

• Time immunisation

  7 days

• Frequency of hospital admissions

  7 days

• Proportion of children hospitalised for RSV bronchiolitis with viral co-detection

  7 days

Study Arms (2)

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.

Other: No intervention required by the protocol

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.

Other: No intervention required by the protocol

Interventions

No intervention required by the protocol 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.

Case patients; Control patients

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric patients under 12 months of age treated for RSV bronchiolitis (for cases), or for one of the conditions listed in the inclusion criteria (for controls).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (5)

CHU Bondy - Jean Verdier

Bondy, France

Location

CHI Créteil

Créteil, France

Location

Hôpital Armand Trousseau AP-HP

Paris, 75012, France

Location

CHU Robert-Debré

Paris, France

Location

CHU Toulouse-hôpital des Enfants

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 38986058 DERIVED

MeSH Terms

Conditions

Bronchiolitis, Viral

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 11, 2023
• Study Start: October 15, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: August 29, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)