Surveillance of HFMD in Pediatric Outpatients

Hand, Foot and Mouth Disease Clinical Trial

— PMB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263439
• Other study ID #: RNI 2023 MIRAND
• Secondary ID: 2023-A00585-40
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: June 20, 2028

Study information

• Verified date: June 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 20, 2028
• Est. primary completion date: June 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Enterovirus Infections
• Hand, Foot and Mouth Disease
• Herpangina
• Mouth Diseases

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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