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

Sponsor
Fundacion GESICA (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05919277
Collaborator
Merck Sharp & Dohme LLC (Industry)
1,487
12

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dengue Immunoglobulin G antibodies performed with ELISA

Detailed 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

Study Type:
Observational
Anticipated Enrollment :
1487 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Seroprevalence [Through study completion, an average of 1 year]

    Percentage of the population with Immunoglobulin G antibodies against dengue fever

Secondary Outcome Measures

  1. Other flavivirus prevalence [Through study completion, an average of 1 year]

    Percentage of population with Immunoglobulin G antibodies to dengue, but found to be cross-reactive to other flaviviruses on plaque neutralization.

  2. Specific dengue serotype [Through study completion, an average of 1 year]

    Dengue-specific serotype among the Immunoglobulin G-positive population.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
    • Age ≥18 at the time of signing the informed consent.
    • Resident of the Buenos Aires metropolitan area
Exclusion Criteria:
  • To be ≤17 years old.

  • Inability to give informed consent.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fundacion GESICA
  • Merck Sharp & Dohme LLC

Investigators

  • Study Director: Alejandro Macchia, MD, Fundacion GESICA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundacion GESICA
ClinicalTrials.gov Identifier:
NCT05919277
Other Study ID Numbers:
  • DENGUE SEROPREVALENCE IN AMBA
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023