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 : July 24, 2019
Arbovirus refers to a group of viruses transmitted by blood-feeding arthropods. There are hundred which have been shown to cause disease in humans. The incubation period is usually limited between 1 and 15 days. The most common clinical features of infection are 4: algo-eruptive, hemorrhagic fever, neurological or arthritic afflictions.
Dengue is a mosquito-born viral disease caused by 4 different serotypes of virus. Dengue fever (DF) is defined by the sudden onset of fever with non-specific constitutional symptoms, recovery occurring spontaneously after 3 to 7 days.
The infection can sometimes progress to dengue hemorrhagic fever (DHF) 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 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.
Since the early 2000s, the French West Indies and French Guiana have become hyperendemic for dengue with simultaneous circulation of the 4 serotypes, regular large outbreak 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 were described in French Antilles in Nov. 2013. The disease 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 4 to 6 weeks. However, severe clinical forms in early stage 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 they may cause outbreaks with specific severe clinical complications. French interministerial mission on emerging infectious diseases, coordinated by Professor A. Flahault, recommended such studies.
|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 2021|
|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 ]The primary endpoint is a composite endpoint defined as the occurrence, within 12 weeks of the onset of arbovirosis, of at least 1 of the following events: death or shock or internal bleeding, or failure to one or more organs or systems (brain, heart, lung, liver, kidney, hemostasis). Deaths not attributable directly or indirectly to the arbovirosis in question will not be taken into account.
- Specific complications: Onset of hemorrhagic fever (dengue) Onset of encephalitis or neurological disorders (West Nile virus, Japanese encephalitis, Zika virus) Onset of chronic form (Chikungunya) [ Time Frame: 12 weeks ]
The analysis will focus only on patients with biologically confirmed arbovirosis by one of the following exams:
- RT-PCR plasma (arbovirus), or urine (Zika virus),
- Research of the NS1 positive antigen (dengue),
- Significant appearance or increase of the G immunoglobulin directed against the arbovirus in question between an early serum (during the first week following the onset of symptoms) and another taken at least 10 days later
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|
|Hôpital Bichat-Claude Bernard||Recruiting|
|Paris, France, 75018|
|Contact: Sophie MATHERON, MD 01 40 25 78 83 Sophie.email@example.com|
|CH André Rosemond||Recruiting|
|Cayenne, French Guiana, 97300|
|Contact: Félix Djossou, MD firstname.lastname@example.org|
|Principal Investigator: Félix Djossou, MD|
|CHU de Pointe à Pitre/Abymes||Recruiting|
|Pointe à Pitre, Guadeloupe, 97261|
|Contact: Kinda SCHEPPERS, MD 05 90 89 15 89 email@example.com|
|Centre Hospitalier Universitaire de Martinique||Recruiting|
|Fort-de-France, Martinique, 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|
|Principal Investigator:||Andre Cabie, MD||CHU de Martinique|