Ireland
--:--IST
Recruiting Observational

Surveillance of HFMD in Pediatric Outpatients

NCT06263439 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-06-20
Last updated
2024-02-16

Condition(s) studied

Hand, Foot and Mouth DiseaseHerpanginaEnterovirus Infections

Investigational drug(s) / intervention(s)

Throat/buccal swab sample

Throat/buccal swab sample: The study involves the genome detection of enteroviruses in throat or mouth swabs taken from children with a diagnosis of HFMD or herpangina. If positive, the precise type of enterovirus responsible will be identified by sequencing a viral genomic region.

Study summary

The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :

* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV.

Eligibility

Sex
ALL
Min age
—
Max age
10 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged 0 to 10 years presenting with HFMD or herpangina Exclusion Criteria: * Refusal to participate by holders of parental authority * Refusal to participate for children over 3 years of age

Primary outcome measure(s)

  • Prevalence of different types of Enteroviruses — 5 years
    Prevalence of different types of enteroviruses associated with HFMD/Herpangina, determined by genomic detection of an enterovirus in samples sent to the National Reference Laboratory for enteroviruses. This will be carried out on a throat or mouth swab taken from a child seen in consultation for HFMD or herpangina at the time of the patient's inclusion in the study. Genomic detection will be carried out using real-time Reverse Transcription-Polymerase Chain Reaction, the reference method for diagnosing enterovirus infections. The type of enterovirus will then be identified by genotyping the sequence encoding the structural proteins or sequencing the complete enterovirus genome.

Trial sites (1)

FacilityCityRegionStatus
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06263439 on ClinicalTrials.gov ↗ ← All trials in France