Use of PCR-Sars-CoV-2 in Children (VIGIL)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Covid-19

• Study Type: Observational
• Enrollment (Anticipated): 12000

Contacts and Locations

Study Locations

• France
  • Créteil, France
    • Recruiting
    • ACTIV network
  • Créteil, France
    • Recruiting
    • PARI network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Child from birth to 14 years of age consulting their doctor

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children < 15 years old; 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?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Association Clinique Thérapeutique Infantile du val de Marne; GPIP; AFPA; Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

Publications and helpful links

Helpful Links

• From the original SARS-CoV-2 strain to the Omicron variant: Predictors of COVID-19 in ambulatory symptomatic children
• Diagnostic accuracy of SARS-CoV-2 rapid antigen test from self-collected anterior nasal swabs in children compared to rapid antigen test and RT-PCR from nasopharyngeal swabs collected by healthcare workers: A multicentric prospective study
• Assessment of SARS-CoV-2 testing in children during a low prevalence period (VIGIL study 1)

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2020
• Primary Completion (ANTICIPATED): May 30, 2024
• Study Completion (ANTICIPATED): May 30, 2024

Study Registration Dates

• First Submitted: May 30, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VIGIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No