- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03210363
Sero-epidemiology of Priority Arboviruses in French Guiana (EPI-ARBO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
French Guiana is a 250,000 inhabitant's French overseas department located in South America, the epidemiology of arboviruses has recently evolved and marked by important outbreaks.
Dengue remains an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cayenne, France, 97306
- Institut Pasteur de la Guyane
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Guiana resident for at least 6 months and present during the entire study period
- Age between 2 and 75 years old
Exclusion Criteria:
- Subject under guardianship or deprived of liberty by judicial decision
- Subject with any pathology or health problem not compatible with blood sampling
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guiana population
Human Biological samples from Guiana population : Two serum tubes of blood will be collected |
Blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dengue, chikungunya, zika Antibodies detection by multiplex serologic tests
Time Frame: 2 years
|
Description of the virological status of individuals by Mutiplex detection of antibodies directed against dengue, chikungunya and zika arboviruses.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprevalence by area and age
Time Frame: 2 years
|
Estimatation of the frequency of Dengue, Chikungunya and zika infections among the general population of French Guiana by geographical area and by age class
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dengue infections proportion
Time Frame: 2 years
|
Proportion of dengue primary and multiple infections in Guiana population.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claude Flamand, Institut Pasteur de la Guyane
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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