West Indies-French Guiana Dengue Study (DAG)
Recruitment status was Recruiting
Dengue is a mosquito-born viral disease caused by four different serotypes of dengue virus (DENV). Dengue fever (DF) is defined by the sudden onset of fever associated with non specific constitutional symptoms, recovery occurring spontaneously after three to seven days. The infection can sometimes progress to dengue hemorrhagic fever (DHF), a disease characterized by a transient increase in vascular permeability provoking a plasma leakage syndrome. DHF can be complicated by shock and internal hemorrhage. Other rarer but potentially life-threatening complications include encephalitis, hepatitis, rhabdomyolysis, and myocarditis. There is currently no way of predicting the outcome of DF or DHF, and the World Health Organisation (WHO) classification lacks sufficient sensitivity and specificity to recognize and guide the management of severe forms of dengue. The pathophysiology of these severe forms is also poorly known, but it involves both host characteristics (immunological facilitation in case of new infection by a different serotype, and genetic factors), and viral factors. Dengue is an emerging disease in Asia and in South-America, with an exponential increase in the number of reported cases (50 to 100 million per year), the number of affected countries, and the number of severe cases. It affects both children and adults. Since the early 2000s, the French West Indies and French Guiana have become hyperendemic for dengue, with simultaneous circulation of the four serotypes, regular large outbreaks, and severe dengue including fatalities. This epidemiological situation calls for large prospective multicenter cohort studies to characterize severe forms of dengue, to seek predictive factors, and to investigate the pathophysiology of the disease (JL Deen Lancet 2006, A Kroeger Lancet 2006). The 2007-2008 West Indies- French Guiana French interministerial mission on emerging infectious diseases, coordinated by Professor Antoine Flahault, recommended such studies and underlined the excellent situation of Guyana for this type of study, and as an interface for clinical and basic research.
Other: biological sample collection
Other: quality of life questionnaire EuroQol®
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Descriptive and Prognostic Study of Dengue Fever in the French West Indies and French Guiana Based on a Hospital Cohort of Children and Adults With Suspected Dengue Fever|
- Occurrence, during follow-up (for 12 weeks following symptom onset), of shock, internal bleeding, failure of one or several organs or systems (brain, heart, lung, liver, kidney, clotting system), or death. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Onset of dengue hemorrhagic fever (WHO criteria). Changes in quality of life, measured with the EuroQol® questionnaire 3 and 12 weeks after the onset of dengue fever symptoms. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
whole blood, serum, white cells, plasma, DNA
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Other: biological sample collection
Principal objective To identify demographic, clinical, biological, virologic, immunologic and genetic factors associated with or predictive of severe complications of dengue fever (shock, internal bleeding, organ failure, death) in a cohort of children and adults with confirmed dengue fever, receiving early hospital care (within 96 hours following symptom onset) in French West Indies or French Guiana.
- To identify demographic, clinical, biological, virologic, immunologic and genetic factors associated with or predictive of dengue hemorrhagic fever (as defined by the World Health Organisation), and severe complications (shock, internal bleeding, organ failure, death) in the same cohort.
- To identify demographic, clinical, biological, virologic, immunologic and genetic factors predictive of altered quality of life after the acute phase of dengue fever in the same cohort.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099852
|CH André Rosemond||Recruiting|
|Cayenne, Guiana, France, 97300|
|Contact: Félix Djossou, MD email@example.com|
|Principal Investigator: Félix Djossou, MD|
|Centre Hospitalier Universitaire de Fort-de-France||Recruiting|
|Fort-de-France, Martinique, France, 97200|
|Contact: Janick Jean-Marie 592697 ext 0596 firstname.lastname@example.org|
|Contact: Paul Mourlhou 592697 ext 0596 email@example.com|
|Principal Investigator: André Cabié, MD|