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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hand, Foot and Mouth Disease
• Intervention / Treatment: Diagnostic test: PCR

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nina Dwi Putri; Phone Number: 021-22391158; Email: ninadwip@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with clinically diagnosed cases of HFMD will be enrolled during the epidemic season within one year or earlies.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case cohort; Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites	Diagnostic test: PCR; PCR test for EV71, CA16, CA10, or CA6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: PRO-EV71/CA16-5002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No