NCT01104740

Brief Summary

Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
817

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

April 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

April 14, 2010

Last Update Submit

August 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence or not of dengue virus-specific immunoglobulin G antibodies

    1 day

Secondary Outcomes (1)

  • Characterization of dengue virus serotype-specific IgG

    1 day

Interventions

Blood (serum) sample collection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, résidents in Martinique/ Guadeloupe (french west indies), aged 18 to 65 years coming to give their blood in one of the building or mobile collection facilities of the French Blood Establishment in French West Indies.

You may qualify if:

  • Eligible for blood donation following the French legislation,
  • Resident in Martinique /Guadeloupe for at least one year
  • Consent signed

You may not qualify if:

  • Not Eligible for blood donation following the French legislation,
  • Not Resident in Martinique / Guadeloupe for at least one year
  • Consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

French Blood Establishment of Guadeloupe

Pointe-à-Pitre, 97171, Guadeloupe

Location

French Blood Establishment of Martinique

Fort-de-France, 97264, Martinique

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Pascale RICHARD, MD

    French Blood Establishment of Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Directrice EFS Martinique

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 15, 2010

Study Start

May 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2012

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations