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

Dengue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919277
• Other study ID #: DENGUE SEROPREVALENCE IN AMBA
• Status: Recruiting
• Start date: September 11, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Fundacion GESICA
• Contact: Cristian Biscayart, MD
• Phone: 541145204002
• Email: cristianbiscayart[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1487
• Est. completion date: September 2024
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dengue
• Flavivirus Infections

Intervention

Diagnostic Test:
• Dengue Immunoglobulin G antibodies performed with ELISA
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.

Locations

Country	Name	City	State
Argentina	Fundación GESICA	Ciudad Autónoma de Buenos Aire	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion GESICA	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprevalence	Percentage of the population with Immunoglobulin G antibodies against dengue fever	Through study completion, an average of 1 year
Secondary	Other flavivirus prevalence	Percentage of population with Immunoglobulin G antibodies to dengue, but found to be cross-reactive to other flaviviruses on plaque neutralization.	Through study completion, an average of 1 year
Secondary	Specific dengue serotype	Dengue-specific serotype among the Immunoglobulin G-positive population.	Through study completion, an average of 1 year