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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05348655
Other study ID # 502_3
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2022
Est. completion date July 2025

Study information

Verified date April 2022
Source Hospices Civils de Lyon
Contact Dominique PLOIN, PhD
Phone 04 27 85 56 42
Email dominique.ploin@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The magnitude of seasonal RSV epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" or NPI. Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions. On a previous study (see NTC 04944160), 519 infants were recruited in the Pre-Covid-19 season population, and 277 infants were recruited in the first Per-Covid-19 season population.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria: - Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France - Positive RSV-PCR Exclusion Criteria: - Parent's refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
epidemiology
To review of medical records to describe diagnosis and severity of the disease
epidemiology
To compare pre- and per-Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.

Locations

Country Name City State
France Pediatric Departement Lyon
France Virology Lab Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annual evolution of the number and severity of RSV-infection in hospitalized children during per-Covid-19 epidemic compared to pre-Covid-19 pandemic. Description of number of cases for each clinical picture according to pre-SARS-CoV-2 pandemic and per-SARS-CoV-2 pandemic year. Day 0
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