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临床试验/NCT05919277
NCT05919277招募中不适用

A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires

Fundacion GESICA1 个研究点 分布在 1 个国家目标入组 1,487 人开始时间: 2023年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,487
试验地点
1
主要终点
Seroprevalence

研究概览

简要总结

The objective of this observational study of dengue seroprevalence in the metropolitan area of Buenos Aires is to know what percentage of the population has antibodies against dengue in persons 18 years of age or older who are residents of the city of Buenos Aires or its metropolitan area. The main questions to be answered are:

  • What is the seroprevalence of antibodies against dengue measured by Immunoglobulin G determination by ELISA
  • Characterize the different dengue serotypes in the affected population. Participants will undergo a small blood draw to determine the presence of Immunoglobulin G antibodies against dengue.
  • Tests will also be performed to determine infection by flaviviruses other than dengue virus.

详细描述

A two-stage stratified design will be used. The primary sampling units will be mostly defined as the census sections of the 2010 National Census of Population, Households and Dwellings. It has 5 strata, constructed through a functional relationship between the income quintiles obtained in the Annual Household Survey (AHS) and the variables that were surveyed in the census. Stratum 1 corresponds to the lowest income population, while stratum 5 corresponds to the highest. The first stage of sampling in this framework will consist of about 100 to 300 primary sampling units, called primary units areas, selected with a probability proportional to size, the measure of size being the total number of dwellings.

A sample of 1,487 dwellings is proposed. In each primary unit area, a number of dwellings will be selected to be visited by enumerators, who will make a list of all members residing in the dwelling (regardless of whether they are from the same household) and select a member aged ≥18 years to proceed with the survey. This last selection is a 3rd and final sampling stage that will define the sample of 1487 participants to be tested. The sample size was calculated based on the estimated probability of pre-infection for each of the municipalities and localities participating in the survey.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Age ≥18 at the time of signing the informed consent.
  • - Resident of the Buenos Aires metropolitan area

排除标准

  • To be ≤17 years old.
  • Inability to give informed consent.

结局指标

主要结局

Seroprevalence

时间窗: Through study completion, an average of 1 year

Percentage of the population with Immunoglobulin G antibodies against dengue fever

次要结局

  • Other flavivirus prevalence(Through study completion, an average of 1 year)
  • Specific dengue serotype(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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