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Completed

NCT Number: NCT06030505

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

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.

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Key information

Conditions

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

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bondy - Jean Verdier, Bondy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients passively immunised with nirsevimab

    Time frame: 7 days

    Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group

Secondary outcomes

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

    Time frame: 7 days

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

  2. Length of hospital stay

    Time frame: 7 days

    Length of hospital stay for children with RSV bronchiolitis.

  3. Time immunisation

    Time frame: 7 days

    Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.

  4. Frequency of hospital admissions

    Time frame: 7 days

    Monthly frequency of hospital admissions for RSV bronchiolitis among participating centres over time

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

    Time frame: 7 days

    Proportion of children hospitalised for RSV bronchiolitis with viral co-detection or viral detection other than RSV on nasopharyngeal swab

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: ENVIE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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