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

NCT05919277 | Unknown DMC

• 1 other identifier: DENGUE SEROPREVALENCE IN AMBA
• Study Type: observational
• Target: 1,487
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue; Flavivirus Infections

Outcome Measures

Primary Outcomes (1)

• Seroprevalence

  Percentage of the population with Immunoglobulin G antibodies against dengue fever

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Other flavivirus prevalence

  Through study completion, an average of 1 year

• Specific dengue serotype

  Through study completion, an average of 1 year

Interventions

Dengue Immunoglobulin G antibodies performed with ELISA DIAGNOSTIC_TEST

All participants who agree to participate by signing an informed consent form will undergo a finger prick for the determination of Immunoglobulin G antibodies measured by ELISA. In a subgroup of persons who test positive, they will be invited to have blood drawn for neutralization determination in order to study serotypes and the presence of other flaviviruses.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A two-stage stratified design will be used. The primary sampling units will be mostly defined as the census tracts of the 2010 national population, household and housing census. It has 5 strata, constructed through a functional relationship between the income quintiles obtained in the Annual Household Survey (HHS) and variables that were surveyed in the census. Stratum 1 is the lowest income population, while stratum 5 corresponds to the highest. The first stage of sampling in this framework will be made up of nearly 100 to 300 primary sampling units, called UP areas, selected with probability proportional to size, the measure of size being the total number of dwellings. A sample size of 1487 dwellings is proposed.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion GESICA: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Fundación GESICA

Ciudad Autónoma de Buenos Aire, Buenos Aires, C1034ACD, Argentina

RECRUITING

MeSH Terms

Conditions

Dengue; Flavivirus Infections

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Alejandro Macchia, MD

  Fundacion GESICA

  STUDY DIRECTOR

Central Study Contacts

Cristian Biscayart, MD

CONTACT

541145204002; cristianbiscayart@gmail.com

Patricia Angeleri, MD

CONTACT

541145204002; pangeleri@intramed.net

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 26, 2023
• Study Start: September 11, 2023
• Primary Completion: December 1, 2023
• Study Completion: September 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)