Surveillance of HFMD in Pediatric Outpatients

NCT ID: NCT06263439

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2028-06-20

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with hand, foot and mouth disease or herpangina

Children with hand, foot and mouth disease or herpangina will be proposed to have a throat or buccal swab collected to do the diagnosis of an enterovirus infection.

Throat/buccal swab sample

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Enterovirus genome detection (Enterovirus R-gene, bioMérieux)

Eligibility Criteria

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

• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audrey MIRAND

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

Other Identifiers

2023-A00585-40

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2023 MIRAND

Identifier Type: -

Identifier Source: org_study_id