ClinicalTrials.gg
RecruitingNCT05919277Updated Sep 13, 2023

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

An observational study in Dengue and Flavivirus Infections, sponsored by Fundacion GESICA. Recruiting at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Fundacion GESICA · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,487
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Dengue
  • Flavivirus Infections

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03

In context

Dengue

283 studies on the registry are indexed under Dengue; 44 are open to participants now.

This study's planned enrollment of 1,487 is above the median of 595 across 80 observational studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Fundacion GESICA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • To be ≤17 years old.
  • Inability to give .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,487 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testDengue 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.

06

What researchers measure

Primary outcomes

  1. Seroprevalence

    Percentage of the population with Immunoglobulin G antibodies against dengue fever

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Other flavivirus prevalence

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

    Time frame: Through study completion, an average of 1 year

  2. Specific dengue serotype

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

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Dec 2023, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 13, 2023
First posted
Jun 26, 2023
StartActual
Sep 11, 2023
Primary completionEst.
Dec 2023
CompletionEst.
Sep 2024
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05919277
Lead sponsor
Fundacion GESICA
Responsible party
Sponsor
First posted
Jun 26, 2023
Start date
Sep 11, 2023
Primary completion
Dec 2023 (estimated)
Completion
Sep 2024 (estimated)
Last update
Sep 13, 2023

Study contacts

Cristian Biscayart, MD
Contact
cristianbiscayart@gmail.com
541145204002
Patricia Angeleri, MD
Contact
pangeleri@intramed.net
541145204002
Alejandro Macchia, MD
study director · Fundacion GESICA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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