Use of PCR-Sars-CoV-2 in Children

NCT ID: NCT04412317

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-03

Study Completion Date

2024-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role collaborator

Groupe de Pathologies Infectieuses Pédiatriques (GPIP)

OTHER

Sponsor Role collaborator

AFPA

UNKNOWN

Sponsor Role collaborator

Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ACTIV network

Créteil, , France

Site Status RECRUITING

PARI network

Créteil, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Corinne Levy, MD

Role: CONTACT

148850404 ext. 33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Corinne LEVY, MD

Role: primary

148850404 ext. 33

Corinne Levy, MD

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/36116761/

From the original SARS-CoV-2 strain to the Omicron variant: Predictors of COVID-19 in ambulatory symptomatic children

https://pubmed.ncbi.nlm.nih.gov/36210936/

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

https://pubmed.ncbi.nlm.nih.gov/34271254/

Assessment of SARS-CoV-2 testing in children during a low prevalence period (VIGIL study 1)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VIGIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitality in Infants Via Azithromycin for Neonates Trial
NCT05763693 NOT_YET_RECRUITING PHASE4