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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06251219
• Other study ID #: PRO-EV71/CA16-5002
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Sinovac Biotech Co., Ltd
• Contact: Nina Dwi Putri
• Phone: 021-22391158
• Email: ninadwip[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Diagnostic Test:
• PCR
PCR test for EV71, CA16, CA10, or CA6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6	Proportions of clinically diagnosed HFMD children who are PCR- positive for EV71, CA16, CA10, or CA6	12 months
Secondary	To describe the clinical manifestation (symptom and severity etc.) of clinically diagnosed HFMD children	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.	12 months
Secondary	To describe the genotypes of HFMD cases caused by EV71, CA16, CA10, and CA6	Frequency of the genotypes of EV71, CA16, CA10 or CA6 in PCR- positive cases	12 months
Secondary	To investigate role of previous infection of enterovirus EV71, coxsackie virus	Proportions of participants who have previous infection (SVNT, and PRNT) of EV71, Coxsackie virus	12 months