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CompletedNCT06030505ENVIEUpdated Aug 29, 2025

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

An observational study in Bronchiolitis, Viral, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 5 sites in France. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Centre Hospitalier Intercommunal Creteil · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,140
Ages
Up to 1 Year
Sex
All
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Study 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.

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Conditions studied

  • Bronchiolitis, Viral

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03

In context

Bronchiolitis, Viral

30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.

Browse Bronchiolitis, Viral studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refusal to participate by the patient, their relative or legal representative
  • Administration of Palivizumab.
  • Maternal vaccination against RSV.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,140 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo 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.

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What researchers measure

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

    Time frame: 7 days

Secondary outcomes

  1. 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

    Time frame: 7 days

  2. Length of hospital stay

    Length of hospital stay for children with RSV bronchiolitis.

    Time frame: 7 days

  3. Time immunisation

    Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.

    Time frame: 7 days

  4. Frequency of hospital admissions

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

    Time frame: 7 days

  5. 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

    Time frame: 7 days

07

Study locations

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

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. PubMed 38986058 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06030505
Responsible party
Sponsor
First posted
Sep 11, 2023
Start date
Oct 15, 2023
Primary completion
Dec 29, 2023
Completion
Dec 29, 2023
Last update
Aug 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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