ENVIE: Effectiveness of Nirsevimab in Children Hospitalised With Bronchiolitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients passively immunised with nirsevimab [1 month]
Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group
Secondary Outcome Measures
- Proportion of hospitalised children for bronchiolitis passively immunised with nirsevimab [1 month]
Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis
- Proportion of hospitalised children for bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab [1 month]
Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis requiring invasive or non-invasive ventilatory support, including RSV bronchiolitis
- Length of hospital stay [1 month]
Length of hospital stay for children with bronchiolitis, including RSV bronchiolitis.
- Time immunisation [1 month]
Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.
- Frequency of hospital admissions [1 month]
Monthly frequency of hospital admissions for bronchiolitis among participating centres over time
- fall in bronchiolitis attributable to the nirsevimab [1 month]
Fraction of the fall in bronchiolitis attributable to the nirsevimab immunisation campaign
- Proportion of children hospitalised for bronchiolitis with viral co-detection [1 month]
Proportion of children hospitalised for bronchiolitis with viral co-detection or viral detection other than RSV on nasopharyngeal swab
Eligibility Criteria
Criteria
Inclusion Criteria:
Cases :
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Children under 12 months of age
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Treated for acute bronchiolitis defined according to current national and international recommendations.
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Admitted to paediatric emergency department.
Controls :
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Children under 12 months
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Cared for at one of the study sites
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From 15 October 2023
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For one of the following reasons
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Febrile urinary tract infection, without acute ear, nose, and throat (ENT) or respiratory symptoms
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Acute gastroenteritis, without acute ENT or respiratory symptoms
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Infant colic without fever, without ENT or acute respiratory symptoms
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Stagnant weight or feeding difficulties without fever, acute ENT or respiratory symptoms
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Neonatal jaundice without fever or acute ENT or respiratory symptoms
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Unexplained crying without fever, without ENT or acute respiratory symptoms
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Head injury, without acute ENT or respiratory symptoms
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Patient hospitalised for acute surgery without fever, without ENT or acute respiratory symptoms
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Hospitalised in the conventional sector or in a short-term hospital unit, or cared for on an outpatient basis
Exclusion Criteria:
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Refusal to participate by the patient, their relative or legal representative
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Administration of Palivizumab.
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Maternal vaccination against RSV.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Bondy - Jean Verdier | Bondy | France | ||
| 2 | CHI Créteil | Créteil | France | ||
| 3 | CHU Robert-Debré | Paris | France | ||
| 4 | CHU Toulouse-hôpital des Enfants | Toulouse | France |
Sponsors and Collaborators
- Centre Hospitalier Intercommunal Creteil
- Association Clinique Thérapeutique Infantile du val de Marne
- Groupe de Pathologies Infectieuses Pédiatriques (GPIP
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENVIE
- 2023-A01803-42