Use of PCR-Sars-CoV-2 in Children

NCT04412317 | Unknown

• 1 other identifier: VIGIL
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 2

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).

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of symptomatic children

  the day of PCR or RAD result

• presence or absence of positive people in close contacts

  the day of PCR or RAD result

• Percentage of RAD RSV and Flu positive in children with respiratory tract infection

  the day of PCR or RAD result

• Accuracy of antigen test compared to PCR

  the day of PCR or RAD result

Study Arms (1)

Children < 15 years old

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

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Child from birth to 14 years of age consulting their doctor

You may qualify if:

• Children under 15 years of age
• Prescription of a PCR-Sars-CoV-2
• VIGIL information note given to parents

You may not qualify if:

• Refusal to participate by the patient, family member or legal representative (depending on the situation)

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator
• Groupe de Pathologies Infectieuses Pédiatriques (GPIP): collaborator
• AFPA: collaborator
• Francophone Pediatric Resuscitation and Emergency Group (GFRUP): collaborator

Study Sites (2)

ACTIV network

Créteil, France

RECRUITING

PARI network

Créteil, France

RECRUITING

Related Links

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Corinne Levy, MD

CONTACT

148850404; corinne.levy@activ-france.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 2, 2020
• Study Start: June 3, 2020
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (2)