Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia

Not yet recruiting

• Conditions: Hand, Foot and Mouth Disease
• Interventions: Diagnostic Test: PCR

• Registration Number: NCT06251219
• Lead Sponsor: Sinovac Biotech Co., Ltd

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.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case cohort	PCR	Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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