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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04944160
Other study ID # 502
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date June 28, 2021

Study information

Verified date June 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The magnitude of seasonal Respiratory Syncytial Virus (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" (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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date June 28, 2021
Est. primary completion date May 15, 2021
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 - Polymerase Chain Reaction (PCR) positive at Respiratory Syncytial Virus (RSV) Exclusion Criteria: - • Parent's refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Groupement Hospitalier EST - Hospices Civils de Lyon Bron

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 Reduction of the number of children hospitalized for a RSV-infection during pre and post-Covid-19 pandemic RSV-winter-epidemic. 2019-2020-winter-epidemic and 2020-2021-winter-epidemic are assessed during June and July, 2021.
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