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

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Covid-19

Study type: Observational

Funder types: Other

Identifiers

NCT04412317

VIGIL

Details and patient eligibility

About

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).

Enrollment: 12,000 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

12,000 participants in 1 patient group

Children < 15 years old

Description:

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