Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251219
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-02-01
Brief Title:
Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia
Sponsor:
Sinovac Biotech Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
An observational study of active case surveillance to identify the pathogens of clinically diagnosed HFMD cases aged 6 months to 18 years old recruited from puskesmas and hospitals in Indonesia
Detailed Description:
Every time suspected case of HFMD presented to the hospital the pediatrician will inform the patient to enroll in the study After the subject signs the informed consent the pediatrician will give the subject designated number to enroll to the study After gathering general information medical history and physical examination the eligibility of participants will be assessed The subject that fulfills the eligibility criteria will be enrolled in the study All participants will collect stool sample or rectal swab to be tested with PCR test for EV71 CA planned serotypes 16106 If the result is positive the sample will be further tested with genotype sequencing of EV71 and CoxA For subject with respiratory symptom skin lesion or encephalitis extra PCR testing will be collected for PCR testing Blood sample will also be collected from all subjects Only 20 subjects with positive PCR result that will be tested for SVNT and PRNT Two weeks following participant recruitment study staff will contact the participant by phone and document the outcome of the disease as well the subjects condition
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