Cohort of Patients Infected by an Arbovirus (CARBO)
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|ClinicalTrials.gov Identifier: NCT01099852|
Recruitment Status : Recruiting
First Posted : April 8, 2010
Last Update Posted : October 27, 2016
Arbovirus is term used to refer to a group of viruses that are transmitted by blood-feeding arthropods. The word arbovirus is an acronym (Arthropod-Borne virus). There are hundred which have been shown to cause disease in humans. The incubation period is short usually limited between 1 and 15 days. Among case in which symptoms do appear, the most common clinical features of infection are 4: algo-eruptive (dengue, chikungunya, Zika virus disease...), hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West Nile virus disease, Zika virus disease, Japanese encephalitis.) or arthritic afflictions, (Chikungunya, O'nyong nyong…).
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.
. 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.
Chikungunya is a re-emerging alphavirus causing massive epidemics in Africa, in the Indian Ocean, and Southeast Asia. The first autochthonous cases of chikungunya were described in French Antilles in November 2013. The disease typically consists of an acute illness like dengue fever, characterized by abrupt onset of a high-grade fever, followed by constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves within à few weeks: four to six weeks. However, severe clinical forms in early stage (encephalopathy, exacerbation of previous complaints..) may appear and chronic forms such as incapacitating arthralgia which affect 40 to 60% of patients with confirmed chikungunya.
In France, others arboviruses may cause severe emerging and re-emerging infectious diseases like Zika or West Nile. In non-immunized population these emerging diseases may cause outbreaks with specific severe clinical complications from each arbovirus (polyradiculoneuritis for Zika virus infection, encephalitis for West Nile virus infection…)
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.
This epidemiological situation calls for large prospective multicenter cohort studies to characterize severe forms of arbovirus infections, to seek predictive factors, and to investigate the pathophysiology of the diseases .
|Condition or disease||Intervention/treatment|
|Fever Dengue Chikungunya Zika Virus||Other: biological sample collection Other: quality of life questionnaire EuroQol® Other: Health Assessment Questionnaire - MDHAQ and RAPID3|
Principal objective To identify demographic, clinical, biological, virologic, immunologic and genetic factors associated with or predictive of severe complications of arbovirus infections (shock, internal bleeding, organ failure, death) in a cohort of children and adults with confirmed arbovirus infections, in France.
To identify demographic, clinical, biological, virologic, immunologic and genetic factors predictive of altered quality of life after confirmed an acute arbovirus infection. Onset of specific complications:
- Hemorrhagic fever (dengue :WHO criteria..)
- Neurological disorders (West Nile virus infection, Zika virus infection, Japanese encephalitis…)
- Chronic chikungunya (persistent musculoskeletal symptoms for more than three months after symptoms onset)
|Study Type :||Observational|
|Estimated Enrollment :||1377 participants|
|Official Title:||Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.r|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2021|
- 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.
- Other: Health Assessment Questionnaire - MDHAQ and RAPID3
Questionnaire used at the 3rd month of follow up.
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
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): NCT01099852
|Contact: Andre Cabiefirstname.lastname@example.org|
|CH André Rosemond||Recruiting|
|Cayenne, Guiana, France, 97300|
|Contact: Félix Djossou, MD email@example.com|
|Principal Investigator: Félix Djossou, MD|
|Centre Hospitalier Universitaire de Martinique||Recruiting|
|Fort-de-France, Martinique, France, 97200|
|Contact: Janick Jean-Marie 592697 ext 0596 firstname.lastname@example.org|
|Contact: Isabelle Calmont 592697 ext 0596 email@example.com|
|Principal Investigator: André Cabié, MD|
|Hôpital Bichat-Claude Bernard||Recruiting|
|Paris, France, 75018|
|Contact: Sophie MATHERON, MD 01 40 25 78 83 Sophie.firstname.lastname@example.org|
|CHU de Pointe à Pitre/Abymes||Recruiting|
|Pointe à Pitre, Guadeloupe, 97261|
|Contact: Kinda SCHEPPERS, MD 05 90 89 15 89 email@example.com|
|Principal Investigator:||Andre Cabie, MD||CHU de Martinique|