An Epidemiological Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,117
- 试验地点
- 2
- 主要终点
- Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
研究概览
简要总结
The aim of this study is to establish an active surveillance in order to generate dengue disease burden estimates including incidence rates, prevalence data, clinical presentation and cost of illness in Forteleza (Brazil).
详细描述
Prospective cohort study.
The study period initially planned to be two years, is extended by one year to cover one additional dengue season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 5 and 13 years of age (including children at least 5 years of age and excluding children who reached their fourteenth birthday) at the time of enrollment.
- •Written informed consent (and assent when applicable).
- •Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. willingness to do a hospital visit in case of dengue suspicion, willingness to attend the study hospital return for follow-up visits, able to observe for signs of dengue, understand how to take a temperature, etc).
- •Subjects who plan to attend one of the study schools for two school years following enrollment.
排除标准
- •Subjects planning to move from the study area during the two school years following enrollment.
- •Child in care.
- •Enrollment in another study that would conflict with the current study.
研究组 & 干预措施
Study cohort
Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.
干预措施: Data collection (Other)
Study cohort
Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.
干预措施: Blood sample collection (Procedure)
结局指标
主要结局
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
时间窗: At Year 3 (2014)
Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
次要结局
- Number of Dengue Infection Cases by Virus Type (DENV)(From Day 0 to Year 3)
- Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases(From 21 up to 35 days post laboratory confirmed dengue onset)
- Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature(From Day 0 to Year 3)
- Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection(At Year 3 (2014))
- Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases(At Year 3 (2014))
- Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases(From Year 0 to Year 3)
- Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases(At Year 3 (2014))
- Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism(From 21 up to 35 days post laboratory confirmed dengue onset)
- Number of School Days Missed by Subjects(From 21 up to 35 days post laboratory confirmed dengue onset)
- Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment(At Day 0 (At enrollment))
- Proportion of Subjects With Primary Asymptomatic Dengue Infection(From Day 0 to Year 3)
- Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases(From 21 up to 35 days post laboratory confirmed dengue onset)
- Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism(From 21 up to 35 days post laboratory confirmed dengue onset)
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 to Year 3)
- Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource(From Day 0 to Year 3)
- Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases(From Day 0 to Year 3)
- Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases(From Day 0 to Year 3)
- Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms(From Day 0 to Year 3)