RSV Burden in Outpatient and Hospital Settings
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-24
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne
About this trial
Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Acute purulent otitis media (Paradise Criteria) or otorrhea with or withitout associated bronchiolitis
Disqualifiers
Age >24 months
Refusal by one of the parents
Not affiliated to a social security system
Maternal RSV vaccination during the pregnancy of the included child
Trial design
Design model
Single group
Treatments tested in this trial
nasopharyngeal samples
Diagnostic testrapid antigen test for Sars Cov-2, influenza and RSV.
Treatment groups
1,900 Participants
are divided into 2 treatment groupsGroup A: Otitis associated with BronchiolitisExperimental treatment 1 intervention
Group B: Otitis not associated with BronchiolitisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
day of enrollmentSecondary outcomes
1
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
Time frame
day of enrollment2
Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients
Assessment of the effect of nirsevimab prophylaxis on the frequency and severity of otitis media, with or without bronchiolitis.
Time frame
day of enrollment3
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.
Time frame
day of enrollment4
Patient care pathway documentation
Number and type of healthcare non-protocol visits, treatments received, and complications
Time frame
day of enrollment, at days 15 and at 6 months after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Association Clinique Thérapeutique Infantile du val de Marne
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov