Clinical trial NCT06030505: Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
Official title: Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis, Viral
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 963
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: Proportion of patients passively immunised with nirsevimab
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of hospitalised children for RSV bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab
timeFrame: 7 days
measure: Length of hospital stay
timeFrame: 7 days
measure: Time immunisation
timeFrame: 7 days
measure: Frequency of hospital admissions
timeFrame: 7 days
measure: Proportion of children hospitalised for RSV bronchiolitis with viral co-detection
timeFrame: 7 days
Other outcomes:
Locations:
city: Bondy
country: France
facility: CHU Bondy - Jean Verdier
city: Créteil
country: France
facility: CHI Créteil
city: Paris
country: France
facility: Hôpital Armand Trousseau AP-HP
city: Paris
country: France
facility: CHU Robert-Debré
city: Toulouse
country: France
facility: CHU Toulouse-hôpital des Enfants
Study officials:
References: