DengSeroprevAn: Dengue Seroprevalence Study in Blood Donors in the French West Indies

• Sponsor: Etablissement Français du Sang, Martinique (Other)
• Overall Status: Completed
• CT.gov ID: NCT01104740
• Collaborator: Sanofi Pasteur, a Sanofi Company (Industry), Institut National de la Santé Et de la Recherche Médicale, France (Other), Clinique Antilles-Guyane (Other)
• Enrollment: 817
• Locations: 2
• Duration (Months): 12
• Patients Per Site: 408.5
• Patients Per Site Per Month: 34

Study Details

Study Description

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	Phase
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.

1. Secondary objective:

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

Study Design

• Study Type: Observational
• Actual Enrollment: 817 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Dengue Seroprevalence Study in Blood Donors in the French West Indies
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2012

Outcome Measures

Primary Outcome Measures

1. Presence or not of dengue virus-specific immunoglobulin G antibodies [1 day]

Secondary Outcome Measures

1. Characterization of dengue virus serotype-specific IgG [1 day]

   Characterization of dengue virus serotype-psecific IgG whendengue virus serotype-specific immunoglobulin G antibodies Test is positive

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	French Blood Establishment of Guadeloupe	Pointe-à-Pitre		Guadeloupe	97171
2	French Blood Establishment of Martinique	Fort-de-France		Martinique	97264

Sponsors and Collaborators

• Etablissement Français du Sang, Martinique
• Sanofi Pasteur, a Sanofi Company
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RICHARD, Directrice EFS Martinique, Etablissement Français du Sang, Martinique
• ClinicalTrials.gov Identifier: NCT01104740
• Other Study ID Numbers: 10/B/01; 2010-A00385-34
• First Posted: Apr 15, 2010
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Dengue

Study Results

No Results Posted as of Aug 20, 2021