A Cohort Study to Assess the Burden of Dengue Illness in Household Members From Selected Communities in Southeast Asia and Latin America
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,750
- 试验地点
- 3
- 主要终点
- Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
研究概览
简要总结
The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.
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
- 6 Months 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written and signed informed consent (and assent if the subject is below the legal age of consent) obtained from the subject/from subject's parent(s)/LAR(s). For a subject below the legal age of consent is, his/her signature will be obtained on the informed assent form, if applicable.
- •A male or female between, and including 6 months and 50 years of age at the time of enrolment (Subjects become ineligible on their 51st birthday).
- •Subject and/or the subject's parent(s)/LAR(s) who the investigator believes can comply with the requirements of the protocol (e.g., willingness to go to the hospital/healthcare centre for visit(s) in case of acute febrile illness, able to observe the signs of dengue and to understand how to take and report body temperature, etc).
- •Subject who plans, at the time of enrolment, to remain at same residence/study area during the one or two year study period (as applicable).
- •Household should be reachable by phone (residence phone or mobile phone). Note: Pregnant or lactating female or female planning to become pregnant can be recruited into the study.
排除标准
- •Child in care.
- •Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
- •Terminal illness or severe mental incapacity.
研究组 & 干预措施
Total Group
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches might be considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
干预措施: Blood sample collection (Procedure)
结局指标
主要结局
Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
时间窗: From Day 0 to Month 24 (study end)
Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
次要结局
- Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.(From Day 0 to Month 24 (study end))
- Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits(From Day 0 to Month 24 (study end))
- Number of Suspected Dengue Cases With Severity Criteria Characteristics(From Day 0 to Month 24 (study end))
- Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico(From Day 0 to Month 24 (study end))
- Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.(At Day 0)
- Number of Subjects With DENV-type Specific Confirmed Symptomatic DENV Infection(From Day 0 to Month 24 (study end))
- Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.(From Day 0 to Month 24 (study end))
- Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.(At Day 0)
- Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure(From Day 0 to Month 24 (study end))