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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05919277
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : September 13, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Fundacion GESICA

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
Dengue Flavivirus Infections 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.

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Study Type : Observational
Estimated 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
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Seroprevalence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through study completion, an average of 1 year ]
    Dengue-specific serotype among the Immunoglobulin G-positive population.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05919277


Contacts
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Contact: Cristian Biscayart, MD 541145204002 cristianbiscayart@gmail.com
Contact: Patricia Angeleri, MD 541145204002 pangeleri@intramed.net

Locations
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Argentina
Fundación GESICA Recruiting
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1034ACD
Contact: Alejandro Macchia, MD    +541149530696    alejandro.macchia@fundaciongesica.org.ar   
Contact: Alejandro Macchia, MD    +541149530696    alejandromacchia100@gmail.com   
Sponsors and Collaborators
Fundacion GESICA
Merck Sharp & Dohme LLC
Investigators
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Study Director: Alejandro Macchia, MD Fundacion GESICA
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Responsible Party: Fundacion GESICA
ClinicalTrials.gov Identifier: NCT05919277    
Other Study ID Numbers: DENGUE SEROPREVALENCE IN AMBA
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dengue
Flavivirus Infections
Mosquito-Borne Diseases
Vector Borne Diseases
Infections
Arbovirus Infections
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs