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临床试验/NCT06251219
NCT06251219尚未招募不适用

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

Sinovac Biotech Co., Ltd0 个研究点目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6

时间窗: 12 months

Proportions of clinically diagnosed HFMD children who are PCR- positive for EV71, CA16, CA10, or CA6

次要结局

  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

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