RSV Burden in Outpatient Settings

Pneumonia Clinical Trial

— Oursyn  

Official title:

Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743609
• Other study ID #: 2020-A02876-33
• Status: Recruiting
• Start date: February 8, 2021
• Est. completion date: January 11, 2024

Study information

• Verified date: December 2022
• Source: Association Clinique Thérapeutique Infantile du val de Marne
• Contact: Corinne Levy, MD
• Phone: 0033148850404
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 24 Months

Eligibility

Inclusion Criteria:

• children under 24 months of age (=)

• One of the holders of parental authority signed the consent

• Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)

• First episode of bronchiolitis defined by

• Age =24 months

• At least one symptom from group A and one symptom from group B Group A (one or more)

• Fever >38 °C

• Cough

• Otalgia

• Nasal congestion

• Rhinorrhea

• Coryza

• Dysphagia Group B (one or more)

• whistling

• Crackles

• Rales

• Decrease in respiratory noise

• Shortness of breath

• Dyspnea

• OR Acute purulent otitis media (Paradise Criteria) or otorrhea.

• OR Pneumonia defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever

Exclusion Criteria:

• Age >24 months

• Refusal by one of the parents

• Not affiliated to a social security system

Related Conditions & MeSH terms

• Bronchiolitis
• Children, Only
• Infections
• Otitis
• Otitis Media
• Outpatient
• Pneumonia
• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Diagnostic Test:
• nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients

Locations

Country	Name	City	State
France	ACTIV	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Association Clinique Thérapeutique Infantile du val de Marne	Sanofi

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Pe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSV proven	Percentage of children with proven RSV disease (bronchiolitis, AOM or pneumonia)	day of enrrollement
Secondary	Proportion of Respiratory Tract Infections by RSV Status	Percentage of children with Respiratory Tract Infections by RSV Status	day of enrrollement
Secondary	Proportion of Respiratory Tract Infections with SARS-CoV-2	Percentage of children with Respiratory Tract Infections with SARS-CoV-2	day of enrrollement
Secondary	Proportion of associated complications by RSV status	Percentage of children with associated complications by RSV status	day of enrrollement, 15 days and 6 months
Secondary	Proportion of AOM by RSV status	Percentage of children with AOM by RSV status	day of enrrollement
Secondary	Proportion of pneumonia by RSV status	Percentage of children with pneumonia by RSV status	day of enrrollement
Secondary	Score of Quality of life	Assessed by the quality of life infant scale (from 0-100, so that higher scores indicate better Health-Related Quality of Life)	15 days and 6 months
Secondary	Caracteristic of tests	Sensitivity, specificity, positive predictive value, negative predictive value positive and negative likelihood ratio of the SARS-Cov2, influenza A/B and RSV rapid antigenic test compared to the reference test by multiplex RT-PCR	day of enrrollement

External Links

•   Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021