Dengue Clinical Trial - A Dengue Sero-prevalence Study in the Metropolitan

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05919277
Study type	Observational
Source	Fundacion GESICA
Contact	Cristian Biscayart, MD
Phone	541145204002
Email	cristianbiscayart@gmail.com
Status	Recruiting
Phase
Start date	September 11, 2023
Completion date	September 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms