NCT06263439

Surveillance of HFMD in Pediatric Outpatients

Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth/Herpangina Associated With Enteroviruses in Pediatric Outpatients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Any child presenting signs suggestive of HFMD/Herpangina can be included in the study by one of the investigating paediatricians. After giving the information note to the parents (and to children over 3 years of age) and asking them not to object, the paediatrician collects a throat or mouth swab to confirm the enterovirus infection. At the same time as the swab is taken, anonymised demographic and clinical data are collected by the doctor during the consultation. The sample and the information sheet are sent to the National Reference Laboratory for enteroviruses (Clermont-Ferrand University Hospital).The diagnosis is performed by EV genome detection and if positive, genotyping is done to identify the type of the enteroviruses.

Conditions

• Hand, Foot and Mouth Disease
• Herpangina
• Enterovirus Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-06-20
• Primary completion: 2028-06-20
• Completion: 2028-06-20
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

1 site across 1 country: France