An observational study in Hand, Foot and Mouth Disease, Herpangina and Enterovirus Infections, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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 :
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.
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 :
Herpangina is defined by the presence of oral ulcers located mainly in the posterior part of the oral cavity: palate, uvula.
Exclusion Criteria:
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.
Also known as: Enterovirus genome detection (Enterovirus R-gene, bioMérieux)
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.
Time frame: 5 years
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).
Time frame: 5 years
Plan to share: No
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University Hospital, Clermont-Ferrand