Use of PCR-Sars-CoV-2 in Children

Covid-19 Clinical Trial

— VIGIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04412317
• Other study ID #: VIGIL
• Status: Recruiting
• Start date: June 3, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Corinne Levy, MD
• Phone: 148850404
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Covid-19

Locations

Country	Name	City	State
France	ACTIV network	Créteil
France	PARI network	Créteil

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	AFPA, Association Clinique Thérapeutique Infantile du val de Marne, Francophone Pediatric Resuscitation and Emergency Group (GFRUP), GPIP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Accuracy of antigen test compared to PCR	Sensibility and specificity of the test	the day of PCR or RAD result

External Links

•   Assessment of SARS-CoV-2 testing in children during a low prevalence period (VIGIL study 1)
•   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
•   From the original SARS-CoV-2 strain to the Omicron variant: Predictors of COVID-19 in ambulatory symptomatic children