Hand, Foot and Mouth DiseasePMBNCT06263439
Surveillance of HFMD in Pediatric Outpatients
An observational study of Hand, Foot and Mouth Disease and Herpangina, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Hand, Foot and Mouth Disease, Herpangina, Enterovirus Infections
- What is being tested?
- Throat/buccal swab sample
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2023to 20 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 0 to 10 years presenting with HFMD or herpangina
Who cannot join
- Refusal to participate by holders of parental authority
- Refusal to participate for children over 3 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Audrey Mirand
About this study
Official title: Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth/Herpangina Associated With Enteroviruses in Pediatric Outpatients
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.
Read the 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.
- Being tested
- Throat/buccal swab sample
- Keywords
- Hand, foot and mouth disease, Enterovirus A71, Coxsackievirus A6, Herpangina, Primary care in paediatrics
- Medical subject headings
- Hand, Foot and Mouth Disease, Herpangina, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Throat/buccal swab sampleDiagnostic test
Also called Enterovirus genome detection (Enterovirus R-gene, bioMérieux)
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with hand, foot and mouth disease or herpangina | 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. Receives: Diagnostic Test: Throat/buccal swab sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start20 Jun 2023
- Primary completion20 Jun 2028 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey MIRAND, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263439
- Sponsor's protocol ID
- RNI 2023 MIRAND
- Other IDs
- 2023-A00585-40
- Acronym
- PMB
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth/Herpangina Associated With Enteroviruses in Pediatric Outpatients
- ClinicalTrials.gov ID
- NCT06263439
- Acronym / sponsor ID
- PMB / RNI 2023 MIRAND
- Keywords
- Hand, foot and mouth disease, Enterovirus A71, Coxsackievirus A6, Herpangina, Primary care in paediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Jun 2028 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with hand, foot and mouth disease or herpangina | – | Diagnostic Test: Throat/buccal swab sampleChildren 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. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children aged 0 to 10 years presenting with HFMD or herpangina
Key exclusion criteria (2 listed)
- Refusal to participate by holders of parental authority
- Refusal to participate for children over 3 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Throat/buccal swab sampleAlso: Enterovirus genome detection (Enterovirus R-gene, bioMérieux)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. | Diagnostic test | Children with hand, foot and mouth disease or herpangina |
Primary outcome
Prevalence of different types of Enteroviruses
Time frame: 5 years
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.
1 secondary outcome
Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
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Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
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Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey MIRAND principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand, Foot and Mouth Disease and Herpangina, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different types of Enteroviruses (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.