Clinical trial NCT06263439: Surveillance of HFMD in Pediatric Outpatients
Official title: Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth/Herpangina Associated With Enteroviruses in Pediatric Outpatients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hand, Foot and Mouth Disease
Herpangina
Enterovirus Infections
Keywords: Hand, foot and mouth disease
Enterovirus A71
Coxsackievirus A6
Herpangina
Primary care in paediatrics
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 3000
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Prevalence of different types of Enteroviruses
timeFrame: 5 years
Secondary outcomes:
measure: Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses
timeFrame: 5 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Audrey MIRAND
role: PRINCIPAL_INVESTIGATOR
References: