Surveillance of HFMD in Pediatric Outpatients

NCT06263439 | Recruiting

• 2 other identifiers: RNI 2023 MIRAND2023-A00585-40
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease; Herpangina; Enterovirus Infections

Keywords

Hand, foot and mouth disease; Enterovirus A71; Coxsackievirus A6; Herpangina; Primary care in paediatrics

Outcome Measures

Primary Outcomes (1)

• Prevalence of different types of Enteroviruses

  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.

  5 years

Secondary Outcomes (1)

• Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses

  5 years

Study Arms (1)

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.

Diagnostic Test: Throat/buccal swab sample

Interventions

Throat/buccal swab sample 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.

Also known as: Enterovirus genome detection (Enterovirus R-gene, bioMérieux)

Children with hand, foot and mouth disease or herpangina

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged between 0 and 10 years seen for HFMD/Herpangina by one of the paediatric investigators. HFMD is defined by the presence of at least two of the following clinical signs: * a vesicular or non-vesicular rash on : * the palms of the hands * soles of the feet, or the buttocks * knees or elbows, * mouth or perioral ulcers, * vesicular or non-generalized eruption. Herpangina is defined by the presence of oral ulcers located mainly in the posterior part of the oral cavity: palate, uvula.

You may qualify if:

• Children aged 0 to 10 years presenting with HFMD or herpangina

You may not qualify if:

• Refusal to participate by holders of parental authority
• Refusal to participate for children over 3 years of age

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Throat swab Buccal swab

MeSH Terms

Conditions

Hand, Foot and Mouth Disease; Herpangina; Enterovirus Infections

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Echovirus Infections

Study Officials

• Audrey MIRAND

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: February 16, 2024
• Study Start: June 20, 2023
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): June 20, 2028
• Last Updated: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)