Surveillance of HFMD in Pediatric Outpatients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Throat/buccal swab sample.
- Who it may be relevant to
- Registry conditions: Hand, Foot and Mouth Disease, Herpangina, Enterovirus Infections. Basic parameters: up to 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth/Herpangina Associated With Enteroviruses in Pediatric Outpatients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Prevalence of different types of Enteroviruses [Time frame: 5 years]
Secondary outcome measures (1)
- Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU de Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT06263439 · RNI 2023 MIRAND · 2023-A00585-40