Hand, Foot and Mouth DiseaseNCT06251219
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 Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- PCR
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants with clinically diagnosed cases of HFMD will be enrolled during the epidemic season within one year or earlies.
Who may be able to join
- 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.
Who cannot join
- NA.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- PCR
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRDiagnostic test
PCR test for EV71, CA16, CA10, or CA6
| Study group | Role | What they receive |
|---|---|---|
| Case cohort | Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites Receives: Diagnostic Test: PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251219
- Sponsor's protocol ID
- PRO-EV71/CA16-5002
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia
- ClinicalTrials.gov ID
- NCT06251219
- Acronym / sponsor ID
- PRO-EV71/CA16-5002
- Conditions
- Hand, Foot and Mouth Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case cohort | – | Diagnostic Test: PCRClinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants with clinically diagnosed cases of HFMD will be enrolled during the epidemic season within one year or earlies.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- NA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCRPCR test for EV71, CA16, CA10, or CA6 | Diagnostic test | Case cohort |
Primary outcome
To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6
Time frame: 12 months
Proportions of clinically diagnosed HFMD children who are PCR- positive for EV71, CA16, CA10, or CA6
3 secondary outcomes
To describe the clinical manifestation (symptom and severity etc.) of clinically diagnosed HFMD children
Time frame: 12 months
To describe the genotypes of HFMD cases caused by EV71, CA16, CA10, and CA6
Time frame: 12 months
To investigate role of previous infection of enterovirus EV71, coxsackie virus
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Dwi Putri (021-22391158, ninadwip@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.