Use of PCR-Sars-CoV-2 in Children

Recruiting

• Conditions: Covid-19

• Registration Number: NCT04412317
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-05-30
• Study First Posted: 2020-06-02
• Study Start: 2020-06-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test	At inclusion	Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR

Secondary Outcome Measures

Name	Time	Method
Number of symptomatic children	the day of PCR or RAD result	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
presence or absence of positive people in close contacts	the day of PCR or RAD result	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
Percentage of RAD RSV and Flu positive in children with respiratory tract infection	the day of PCR or RAD result	Number of RAD RSV and Flu positive in children with respiratory tract infection on total number of tests
Accuracy of antigen test compared to PCR	the day of PCR or RAD result	Sensibility and specificity of the test

Trial Locations

Locations (2)

PARI network; 🇫🇷 Créteil, France

ACTIV network; 🇫🇷 Créteil, France