Hand, Foot and Mouth Disease
Conditions
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 16/10/6). 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 subject's condition.
Interventions
DIAGNOSTIC_TESTPCR
PCR test for EV71, CA16, CA10, or CA6
Sponsors
Sinovac Biotech Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites * The participant's parent/ legally accepted representative (LAR) could understand and sign a documented informed consent voluntarily before the study procedures.
Exclusion criteria
* NA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6 | 12 months | Proportions of clinically diagnosed HFMD children who are PCR- positive for EV71, CA16, CA10, or CA6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the clinical manifestation (symptom and severity etc.) of clinically diagnosed HFMD children | 12 months | Distribution of HFMD symptoms and disease severity per predefined age groups, gender group (male and female), region group (urban and rural) and enterovirus type (EV71, CA16, CA10, CA6 and others) group. |
| To describe the genotypes of HFMD cases caused by EV71, CA16, CA10, and CA6 | 12 months | Frequency of the genotypes of EV71, CA16, CA10 or CA6 in PCR- positive cases |
| To investigate role of previous infection of enterovirus EV71, coxsackie virus | 12 months | Proportions of participants who have previous infection (SVNT, and PRNT) of EV71, Coxsackie virus |
Contacts
Primary ContactNina Dwi Putri
Outcome results
None listed