Use of PCR-Sars-CoV-2 in Children

Study Overview
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Brief Summary
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The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). The management of sick young children (with respiratory tract infection that could be attributed to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. Since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening. Because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. However, the identification of the pathogen is the key to improve management of these infectious diseases. The VIGIL study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).

Official Title
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National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study

Conditions
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Covid-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children under 15 years of age Prescription of a PCR-Sars-CoV-2 VIGIL information note given to parents Exclusion Criteria: Refusal to participate by the patient, family member or legal representative (depending on the situation)

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children < 15 years old<br>Patients under 15 years old who consults a physician on an outpatient basis or in the emergency room and who requires a Sars-CoV-2 RT- PCR (nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction) diagnostic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test | Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of symptomatic children | Number of positive PCR result in the sick child in the presence of a Covid contagion in the family environment or not on total number of PCR | the day of PCR or RAD result | 
| presence or absence of positive people in close contacts | Number of RAD-Sars-CoV-2 positive in the sick child in the presence of a Covid contagion in the family environment or not on number of negative RAD-Sars-CoV-2 | the day of PCR or RAD result | 
| Percentage of RAD RSV and Flu positive in children with respiratory tract infection | Number of RAD RSV and Flu positive in children with respiratory tract infection on total number of tests | the day of PCR or RAD result | 
| Accuracy of antigen test compared to PCR | Sensibility and specificity of the test | the day of PCR or RAD result |