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Dengue Seroprevalence Study in Blood Donors in the French West Indies (DengSeroprevAn)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Etablissement Français du Sang, Martinique.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Sanofi Pasteur MSD
Institut National de la Santé Et de la Recherche Médical, France
Centre d'Investigation Clinique-Epidémiologie Clinique Antilles Guyane
Information provided by:
Etablissement Français du Sang, Martinique
ClinicalTrials.gov Identifier:
NCT01104740
First received: April 14, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Blood Donors
Dengue
 Other: Biological sample collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dengue Seroprevalence Study in Blood Donors in the French West Indies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Etablissement Français du Sang, Martinique:

Primary Outcome Measures:
  • Presence or not of dengue virus-specific immunoglobulin G antibodies [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterization of dengue virus serotype-specific IgG [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Characterization of dengue virus serotype-psecific IgG whendengue virus serotype-specific immunoglobulin G antibodies Test is positive


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 770
Study Start Date: June 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Biological sample collection
    Blood (serum) sample collection
Detailed Description:

  1. Principal objective:

    To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.

  2. Secondary objective:

To specify the serotypic specificity of the anti-dengue antibodies detected during the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not Eligible for blood donation following the French legislation,
  • Not Resident in Martinique / Guadeloupe for at least one year
  • Consent not signed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104740

Contacts
Contact: Janick JEAN-MARIE, Master 592697 ext 33596 janick.jean-marie@chu-fortdefrance.fr
Contact: Paul Mourlhou 592697 ext 33596 paul.mourlhou@chu-fortdefrance.fr

Locations
Guadeloupe
French Blood Establishment of Guadeloupe Not yet recruiting
Pointe-à-Pitre, Guadeloupe, 97171
Contact: Rémi Courbil, Ph.D     891555 ext 33590     remi.courbil@efs.sante.fr    
Principal Investigator: Rémi Courbil, Ph.D            
Martinique
French Blood Establishment of Martinique Not yet recruiting
Fort-de-France, Martinique, 97264
Contact: Pascale Richard, MD     757915 ext 33596     pascale.richard@efs.sante.fr    
Principal Investigator: Pascale Richard, MD            
Sponsors and Collaborators
Etablissement Français du Sang, Martinique
Sanofi Pasteur MSD
Institut National de la Santé Et de la Recherche Médical, France
Centre d'Investigation Clinique-Epidémiologie Clinique Antilles Guyane
Investigators
Principal Investigator: Pascale RICHARD, MD French Blood Establishment of Martinique
  More Information

No publications provided

Responsible Party: RICHARD / Chef Executive Officer, Etablissement Français du sang de Martinique
ClinicalTrials.gov Identifier: NCT01104740     History of Changes
Other Study ID Numbers: 10/B/01
Study First Received: April 14, 2010
Last Updated: April 14, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on June 18, 2013