West Indies-French Guiana Dengue Study (DAG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Information provided by:
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01099852
First received: February 23, 2010
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Fever
Dengue
Other: biological sample collection
Other: quality of life questionnaire EuroQol®

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 3000
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)
Intervention Details:
    Other: biological sample collection
    blood sample collection
    Other: quality of life questionnaire EuroQol®
    Changes in quality of life, measured with the EuroQol® questionnaire 3 and 12 weeks after the onset of dengue fever symptoms.
Detailed Description:

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.

Secondary objective

  1. 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.
  2. 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital cohort of children and adults with suspected dengue fever in the French West Indies and French Guiana.

Criteria

Inclusion Criteria:

  • Adult, and child aged at least 8 days and with weight >3 Kg
  • Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit).
  • Clinical and biological signs of dengue fever on the day of enrollment or within the previous 96 hours, namely fever (documented, or reported by the patient or family) and two or more of the following signs: headache, rash, myalgia, arthralgia, abdominal pain, hemorrhage, and thrombocytopenia, and pain in children under 6 years, presence of pain greater than or equal to 4/10 on hetero assessment scale age age-appropriate
  • Symptom onset less than 96 hours before the first hospital visit (enrollment visit).
  • Possibility of follow-up throughout the 12-week study period.
  • Patient or holder of parental authority registered in the French medical social security national program
  • Acceptance to participate in the study and in follow-up; informed consent of the patient (adult and minor in age to express his desire) or a legal representative (for minors, and patients unable to sign the consent form).

Exclusion Criteria:

  • Newborn less than 8 days old or with weight<3Kg
  • Symptom onset more than 96 hours previously
  • Clinical diagnosis of an infection other than dengue.
  • Confirmed Malaria Access
  • No follow-up possible after the first visit
  • Refusal to participate in the study
  • Patient or holder of parental authority not registered in the French medical social security national program
  • Included patient and ongoing followed patient in the study
  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: NCT01099852

Locations
France
CH André Rosemond Recruiting
Cayenne, Guiana, France, 97300
Contact: Félix Djossou, MD       felix.djossou@ch-cayenne.fr   
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    janick.jean-marie@chu-fortdefrance.fr   
Contact: Paul Mourlhou    592697 ext 0596    paul.mourlhou@chu-fortdefrance.fr   
Principal Investigator: André Cabié, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
  More Information

No publications provided

Responsible Party: Daniel RIAM/Chief Executive Officer, Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier: NCT01099852     History of Changes
Other Study ID Numbers: 09/B/08
Study First Received: February 23, 2010
Last Updated: March 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
dengue
fever
dengue hemorrhagic fever
dengue virus

Additional relevant MeSH terms:
Dengue
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014