Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)
The study protocol is designed with three key components: 1. Build on existing PARI outpatient syndromic surveillance by adding laboratory multiplex testing of LRTI samples (RSV, Influenza, SARS-COV-2) 2. Follow all bronchiolitis through the PARI RWE database and document "patient journey" for 5 years after first medical visit 3. Review the electronic PARI data of three previous seasons in order to document the impact of LRTI attributable to RSV in children < 2 years in France prior to enhanced surveillance
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otitis associated with Bronchiolitis | Experimental | Only for city physicians: 800 children presenting with acute otitis media associated with bronchiolitis will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab. |
|
| Otitis not associated with Bronchiolitis | Experimental | Only for city physicians: A total of 1,100 children presenting with acute otitis media, without concomitant bronchiolitis, will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasopharyngeal samples | Diagnostic Test | rapid antigen test for Sars Cov-2, influenza and RSV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics | Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV) | day of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings | Percentage of children with acute otitis media (OMA) testing positive for RSV, with or without concomitant bronchiolitis | day of enrollment |
| Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corinne Levy, MD | Contact | 0033148850404 | corinne.levy@activ-france.fr | |
| Stéphane Béchet, MsC | Contact | 0033148850404 | stephane.bechet@activ-france.fr |
| Name | Affiliation | Role |
|---|---|---|
| Robert Cohen | Association Clinique et Thérapeutique Infantile du Val de Marne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTIV | Recruiting | Créteil | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34260480 | Result | Rybak A, Levy C, Jung C, Bechet S, Batard C, Hassid F, Zouari M, Cahn-Sellem F, Bangert M, Cohen R. Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021. Pediatr Infect Dis J. 2021 Dec 1;40(12):e511-e514. doi: 10.1097/INF.0000000000003270. | |
| 39893316 |
| Label | URL |
|---|---|
| Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021 | View source |
Not provided
Study patients data are stored by ACTIV, but in the event of data transfer to other researchers, they will be fully anonymized.
Data will become available 12 months after publication of the primary results and will be accessible for 5 years
Access will be granted to qualified researchers after submission of a research proposal and approval by ACTIV. All shared data will be fully anonymized to protect participant confidentiality. Use of the data is restricted to scientific research purposes only
Not provided
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
A nasopharyngeal specimen will be obtained from the eligible child. The procedure consists of inserting and gently rotating a swab into the posterior nasopharynx to perform a rapid antigen test (nasopharyngeal or nasal). The test provides results within 10 to 15 minutes and determines the presence or absence of respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2.
Not provided
Not provided
Not provided
Not provided
Assessment of the effect of nirsevimab prophylaxis on the frequency and severity of otitis media, with or without bronchiolitis. |
| day of enrollment |
| Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings | Percentage of otitis media cases associated or not with bronchiolitis caused by SARS-CoV-2. | day of enrollment |
| Patient care pathway documentation | Number and type of healthcare non-protocol visits, treatments received, and complications | day of enrollment, at days 15 and at 6 months after inclusion |
| Score of Quality of life | Health-related quality of life assessed using the PedsQL test, according to RSV status and nirsevimab immunization status. | 15 days and 6 months after inclusion |
| Socioeconomic impact: Parental work absenteeism | Number of days parents miss work due to the child's illness, according to children RSV status and nirsevimab immunization | 15 days and 6 months after inclusion |
| Demographic and clinical characteristics of included children | Analysis of characteristics such as prematurity, comorbidities, and Nirsevimab immunization status | day of enrollment |
| Lenglart L, Levy C, Basmaci R, Levieux K, Kramer R, Mari K, Bechet S, Launay E, Cohen L, Aupiais C, de Pontual L, Rybak A, Lassoued Y, Ouldali N, Cohen R. Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study. Eur J Pediatr. 2025 Feb 1;184(2):171. doi: 10.1007/s00431-025-06008-9. |
| 38900603 | Result | Rybak A, Cohen R, Bangert M, Kramer R, Delobbe JF, Deberdt P, Cahn-Sellem F, Bechet S, Levy C. Assessing the Burden of Respiratory Syncytial Virus-related Bronchiolitis in Primary Care and at 15-Day and 6-Month Follow-up Before Prophylaxis in France: A Test-negative Study. Pediatr Infect Dis J. 2024 Jul 1;43(7):657-662. doi: 10.1097/INF.0000000000004360. Epub 2024 Apr 10. |
| 41862086 | Derived | Lenglart L, Levy C, Batard C, Delobbe JF, Lecailler F, Bechet S, Fafi I, Boulhol M, Kramer R, Rybak A, Ouldali N, Cohen R. Effectiveness of Nirsevimab on Primary Care Visits for Respiratory Syncytial Virus-Associated Acute Otitis Media in Infants. J Pediatr. 2026 Jul;294:115067. doi: 10.1016/j.jpeds.2026.115067. Epub 2026 Mar 19. |
| Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study | View source |
| Assessing the Burden of Respiratory Syncytial Virus-related Bronchiolitis in Primary Care and at 15-Day and 6-Month Follow-up Before Prophylaxis in France: A Test-negative Study | View source |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |