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Sero-epidemiology of Priority Arboviruses in French Guiana (EPI-ARBO)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210363
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Brief Summary:
Dengue is 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.

Condition or disease Intervention/treatment Phase
Arbovirus Infections Other: Human Biological samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2697 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sero-epidemiology of Priority Arboviruses in French Guiana
Actual Study Start Date : June 9, 2017
Actual Primary Completion Date : November 21, 2017
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guiana population

Human Biological samples from Guiana population :

Two serum tubes of blood will be collected

Other: Human Biological samples
Blood sample




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Dengue infections proportion [ Time Frame: 2 years ]
    Proportion of dengue primary and multiple infections in Guiana population.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03210363


Locations
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France
Institut Pasteur de la Guyane
Cayenne, France, 97306
Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Claude Flamand Institut Pasteur de la Guyane
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03210363    
Other Study ID Numbers: 2016-073
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
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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Arbovirus Infections
Virus Diseases