Surveillance of HFMD in Pediatric Outpatients

ConditionsHand, Foot and Mouth Disease Herpangina Enterovirus Infections

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeUp to 10

SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 0 to 10 years presenting with HFMD or herpangina

Disqualifiers

Refusal to participate by holders of parental authority

Refusal to participate for children over 3 years of age

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

3,000 Participants

are divided into 1 treatment group

Group A: Children with hand, foot and mouth disease or herpangina1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov

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