Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis (ENVIE)

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis, Viral
• Intervention / Treatment: Other: No intervention required by the protocol

• Study Type: Observational
• Enrollment (Actual): 1140

Contacts and Locations

Study Locations

• France
  • Bondy, France
    • CHU Bondy - Jean Verdier
  • Créteil, France
    • CHI Créteil
  • Paris, France, 75012
    • Hôpital Armand Trousseau AP-HP
  • Paris, France
    • CHU Robert-Debré
  • Toulouse, France
    • CHU Toulouse-hôpital des Enfants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Length of hospital stay	Length of hospital stay for children with RSV bronchiolitis.	7 days
Time immunisation	Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.	7 days
Frequency of hospital admissions	Monthly frequency of hospital admissions for RSV bronchiolitis among participating centres over time	7 days
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Association Clinique Thérapeutique Infantile du val de Marne; Groupe de Pathologies Infectieuses Pédiatriques (GPIP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis; Bronchitis; Bronchiolitis, Viral
• Other Study ID Numbers: ENVIE; 2023-A01803-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No