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Use of PCR-Sars-CoV-2 in Children

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04412317
Acronym
VIGIL
Enrollment
12000
Registered
2020-06-02
Start date
2020-06-03
Completion date
2024-05-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Brief summary

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).

Interventions

None listed

Sponsors

Association Clinique Thérapeutique Infantile du val de Marne
CollaboratorOTHER
Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
CollaboratorOTHER
AFPA
CollaboratorUNKNOWN
Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
CollaboratorOTHER
Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) testAt inclusionNumber of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR

Secondary

MeasureTime frameDescription
Number of symptomatic childrenthe day of PCR or RAD resultNumber 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
presence or absence of positive people in close contactsthe day of PCR or RAD resultNumber 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
Percentage of RAD RSV and Flu positive in children with respiratory tract infectionthe day of PCR or RAD resultNumber of RAD RSV and Flu positive in children with respiratory tract infection on total number of tests
Accuracy of antigen test compared to PCRthe day of PCR or RAD resultSensibility and specificity of the test

Countries

France

Contacts

Primary ContactCorinne Levy, MD
corinne.levy@activ-france.fr148850404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026