DengueNCT05919277
A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
An observational study of Dengue and Flavivirus Infections, run by Fundacion GESICA at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue, Flavivirus Infections
- What is being tested?
- Dengue Immunoglobulin G antibodies performed with ELISA
- How many people
- 1,487 participants
- Where
- 1 siteArgentina
- Study dates
- 11 Sep 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- - Age ≥18 at the time of signing the informed consent.
- - Resident of the Buenos Aires metropolitan area
Who cannot join
- To be ≤17 years old.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Fundación GESICA
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1034ACD
Alejandro Macchia, MD, +541149530696, alejandro.macchia@fundaciongesica.org.ar
Alejandro Macchia, MD, +541149530696, alejandromacchia100@gmail.com
About this study
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.
- Conditions
- Dengue, Flavivirus Infections
- Being tested
- Dengue Immunoglobulin G antibodies performed with ELISA
- Medical subject headings
- Dengue, Flavivirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue Immunoglobulin G antibodies performed with ELISADiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence
Percentage of the population with Immunoglobulin G antibodies against dengue fever
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Other flavivirus prevalence
Percentage of population with Immunoglobulin G antibodies to dengue, but found to be cross-reactive to other flaviviruses on plaque neutralization.
Measured: Through study completion, an average of 1 year
Specific dengue serotype
Dengue-specific serotype among the Immunoglobulin G-positive population.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start11 Sep 2023
- Primary completionDec 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,487 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion GESICA
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Alejandro Macchia, MD, Study director, Fundacion GESICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919277
- Sponsor's protocol ID
- DENGUE SEROPREVALENCE IN AMBA
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
- ClinicalTrials.gov ID
- NCT05919277
- Acronym / sponsor ID
- DENGUE SEROPREVALENCE IN AMBA
- Conditions
- Dengue, Flavivirus Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,487 participants (estimated)
- Lead sponsor
- Fundacion GESICAUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- - Age ≥18 at the time of signing the informed consent.
- - Resident of the Buenos Aires metropolitan area
Key exclusion criteria (2 listed)
- To be ≤17 years old.
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengue Immunoglobulin G antibodies performed with ELISAAll 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. | Diagnostic test | – |
Primary outcome
Seroprevalence
Time frame: Through study completion, an average of 1 year
Percentage of the population with Immunoglobulin G antibodies against dengue fever
2 secondary outcomes
Other flavivirus prevalence
Time frame: Through study completion, an average of 1 year
Specific dengue serotype
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Macchia, MD study director
Fundacion GESICA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Flavivirus Infections, run by Fundacion GESICA at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristian Biscayart, MD (541145204002, cristianbiscayart@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.