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
Recruitment status was Not yet recruiting
Sponsor:
Etablissement Français du Sang, Martinique
Collaborators:
Sanofi Pasteur MSD
Institut National de la Santé Et de la Recherche Médicale, France
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
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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:
Genetic and Rare Diseases Information Center resources:
Dengue Fever
Hemorrhagic Fever
Viral Hemorrhagic Fever
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:
Detailed Description:
-
Other: Biological sample collection
Blood (serum) sample collection
-
Principal objective:
To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104740
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 Médicale, France
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 Flaviviridae Infections Flavivirus Infections |
Hemorrhagic Fevers, Viral RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on March 01, 2015