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

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ClinicalTrials.gov Identifier: NCT01104740
Recruitment Status : Unknown
Verified April 2010 by Etablissement Français du Sang, Martinique.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2010
Last Update Posted : April 15, 2010
Sponsor:
Collaborators:
MCM Vaccines B.V.
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Information provided by:
Etablissement Français du Sang, Martinique

Study Description
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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.

Condition or disease Intervention/treatment
Blood Donors Dengue Other: Biological 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.


Study Design
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Study Type : Observational
Estimated Enrollment : 770 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dengue Seroprevalence Study in Blood Donors in the French West Indies
Study Start Date : June 2010
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Intervention Details:
    Other: Biological sample collection
    Blood (serum) sample collection

Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Presence or not of dengue virus-specific immunoglobulin G antibodies [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Characterization of dengue virus serotype-specific IgG [ Time Frame: 1 day ]
    Characterization of dengue virus serotype-psecific IgG whendengue virus serotype-specific immunoglobulin G antibodies Test is positive


Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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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): 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
MCM Vaccines B.V.
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Investigators
Principal Investigator: Pascale RICHARD, MD French Blood Establishment of Martinique
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: April 2010

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