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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01803-42 | Other Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Cases :
Controls :
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bondy - Jean Verdier | Bondy | France | ||||
| CHI Créteil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38986058 | Derived | 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. |
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| ID | Term |
|---|---|
| D001990 | Bronchiolitis, Viral |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| 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 |
| Créteil |
| France |
| Hôpital Armand Trousseau AP-HP | Paris | 75012 | France |
| CHU Robert-Debré | Paris | France |
| CHU Toulouse-hôpital des Enfants | Toulouse | France |
| D014777 |
| Virus Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |