NCT06251219

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

February 1, 2024

Last Update Submit

February 1, 2024

Conditions

Hand, Foot and Mouth Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • To describe the clinical manifestation (symptom and severity etc.) of clinically diagnosed HFMD children

    12 months

  • To describe the genotypes of HFMD cases caused by EV71, CA16, CA10, and CA6

    12 months

  • To investigate role of previous infection of enterovirus EV71, coxsackie virus

    12 months

Study Arms (1)

Case cohort

Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites

Diagnostic Test: PCR

Interventions

PCRDIAGNOSTIC_TEST

PCR test for EV71, CA16, CA10, or CA6

Case cohort

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • NA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Nina Dwi Putri

CONTACT

021-22391158ninadwip@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02