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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

Tracking Information
First Submitted Date  ICMJE June 16, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date January 28, 2019
Actual Study Start Date  ICMJE June 9, 2017
Actual Primary Completion Date November 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2017)
Dengue infections proportion [ Time Frame: 2 years ]
Proportion of dengue primary and multiple infections in Guiana population.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Sero-epidemiology of Priority Arboviruses in French Guiana
Official Title  ICMJE Sero-epidemiology of Priority Arboviruses in French Guiana
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Arbovirus Infections
Intervention  ICMJE Other: Human Biological samples
Blood sample
Study Arms  ICMJE Experimental: Guiana population

Human Biological samples from Guiana population :

Two serum tubes of blood will be collected

Intervention: Other: Human Biological samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
2697
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
2500
Estimated Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date November 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03210363
Other Study ID Numbers  ICMJE 2016-073
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Pasteur
Study Sponsor  ICMJE Institut Pasteur
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claude Flamand Institut Pasteur de la Guyane
PRS Account Institut Pasteur
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP