Clinical trial NCT04412317: Use of PCR-Sars-CoV-2 in Children
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
name: Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
name: AFPA
name: Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
First posted: 2020-06-02
Enrollment: 12000
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child from birth to 14 years of age consulting their doctor

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test
timeFrame: At inclusion
Secondary outcomes:
measure: Number of symptomatic children
timeFrame: the day of PCR or RAD result
measure: presence or absence of positive people in close contacts
timeFrame: the day of PCR or RAD result
measure: Percentage of RAD RSV and Flu positive in children with respiratory tract infection
timeFrame: the day of PCR or RAD result
measure: Accuracy of antigen test compared to PCR
timeFrame: the day of PCR or RAD result
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV network
city: Créteil
country: France
facility: PARI network
Study officials:
References: