Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263439
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-06-09
Brief Title:
Surveillance of HFMD in Pediatric Outpatients
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouthHerpangina Associated With Enteroviruses in Pediatric Outpatients
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMB
Brief 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
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 HFMDHerpangina 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 HospitalThe diagnosis is performed by EV genome detection and if positive genotyping is done to identify the type of the enteroviruses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00585-40 | OTHER | ANSM | None |