NCT03210363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,697

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

June 16, 2017

Last Update Submit

September 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dengue, chikungunya, zika Antibodies detection by multiplex serologic tests

    Description of the virological status of individuals by Mutiplex detection of antibodies directed against dengue, chikungunya and zika arboviruses.

    2 years

Secondary Outcomes (1)

  • Seroprevalence by area and age

    2 years

Other Outcomes (1)

  • Dengue infections proportion

    2 years

Study Arms (1)

Guiana population

EXPERIMENTAL

Human Biological samples from Guiana population : Two serum tubes of blood will be collected

Other: Human Biological samples

Interventions

Blood sample

Guiana population

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Guiana resident for at least 6 months and present during the entire study period
  • Age between 2 and 75 years old

You may not qualify if:

  • Subject under guardianship or deprived of liberty by judicial decision
  • Subject with any pathology or health problem not compatible with blood sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur de la Guyane

Cayenne, 97306, France

Location

MeSH Terms

Conditions

Arbovirus Infections

Condition Hierarchy (Ancestors)

Vector Borne DiseasesInfectionsVirus Diseases

Study Officials

  • Claude Flamand

    Institut Pasteur de la Guyane

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

July 6, 2017

Study Start

June 9, 2017

Primary Completion

November 21, 2017

Study Completion

June 30, 2020

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations