Surveillance of HFMD in Pediatric Outpatients

Recruiting

• Conditions: Hand, Foot and Mouth Disease; Enterovirus Infections; Herpangina
• Interventions: Diagnostic Test: Throat/buccal swab sample

• Registration Number: NCT06263439
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-09
• Study Start: 2023-06-20
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2028-06-20
• Study Completion: 2028-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with hand, foot and mouth disease or herpangina	Throat/buccal swab sample	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses	5 years	Comparison between types of enteroviruses determined by genomic detection and clinical characteristics of HFMD/Herpangina. These are collected by the pediatrician during the consultation and include: the nature (throat or mouth) and the date of the sample, the date of onset of the illness, fever, the type and location of rashes, oral ulcerations or perioral, herpangina as well as digestive, ENT, respiratory, neuro-meningeal or other signs (specifying).

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France