Surveillance of HFMD in Pediatric Outpatients (PMB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Enterovirus Infections; Hand, Foot and Mouth Disease; Herpangina
• Intervention / Treatment: Diagnostic test: Throat/buccal swab sample

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: LISE LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Lise Laclautre; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Audrey Mirand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Enterovirus genome detection (Enterovirus R-gene, bioMérieux)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses	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).	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Audrey MIRAND, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): June 20, 2028

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Herpangina; Hand, foot and mouth disease; Enterovirus A71; Coxsackievirus A6; Primary care in paediatrics
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Picornaviridae Infections; Coxsackievirus Infections; Echovirus Infections; Mouth Diseases; Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina
• Other Study ID Numbers: RNI 2023 MIRAND; 2023-A00585-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No