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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Clinique Antilles-Guyane | OTHER |
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There are hundred of arbovirus which have been shown to cause disease in humans. Their most common clinical symptoms are algo-eruptive (dengue, chikungunya, zika), hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West Nile, Zika, dengue, Japanese encephalitis) or arthritic afflictions (Chikungunya, O'nyong nyong). 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 in 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 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 forms is also poorly known. Since 2000s, the French West Indies and Guiana have become hyperendemic for dengue with simultaneous circulation of the 4 serotypes, regular large outbreaks and severe dengue including fatalities. Chikungunya is a re-emerging virus 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 typically consists of an acute illness like dengue fever with abrupt onset of a high-grade fever followed by constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves in 4 to 6 weeks. However, severe clinical forms in early stage may appear and chronic clinical forms as incapacitating arthralgia which affect 40 to 60% of patients. 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. The French interministerial mission on emerging infectious diseases coordinated by Professor Antoine Flahault, recommended such studies: large prospective multicenter cohort studies to characterize severe forms of arbovirus infections to seek predictive factors and to investigate the pathophysiology of the diseases.
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.
Secondary objective
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological sample collection | Other | blood sample collection urine sample cerebrospinal fluid sample | ||
| Quality of life Questionnaire EuroQol® | Other | Changes in quality of life, measured with the EuroQol® questionnaire 3 and 12 weeks after the onset of dengue fever symptoms. | ||
| Health Assessment Questionnaire - MDHAQ and RAPID3 | Other | Questionnaire used at the 3rd month of follow up. | ||
| Neuropathic Pain Questionnaire (DN4) | Other | Questionnaire used during the follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The analysis will focus only on patients with biologically confirmed arbovirosis by one of the following exams:
|
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INCLUSION CRITERIA :
Adult, child or newborn with a weight > 2.5 kg the days of enrollment.
Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit).
Arbovirosis suspected or confirmed biologically: A suspected case of arbovirus infection is defined by:
A case of arbovirus infection confirmed biologically is defined by:
EXCLUSION CRITERIA :
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Hospital cohort of children and adults with suspected of infectious by an arbovirus in the overseas departments and regions and in France.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre Cabie | Contact | 0596552301 | andre.cabie@chu-fortdefrance.fr |
| Name | Affiliation | Role |
|---|---|---|
| Andre Cabie, MD | CHU de Martinique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint André | Recruiting | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37068115 | Derived | Carras M, Maillard O, Cousty J, Gerardin P, Boukerrou M, Raffray L, Mavingui P, Poubeau P, Cabie A, Bertolotti A. Associated risk factors of severe dengue in Reunion Island: A prospective cohort study. PLoS Negl Trop Dis. 2023 Apr 17;17(4):e0011260. doi: 10.1371/journal.pntd.0011260. eCollection 2023 Apr. | |
| 32163420 | Derived |
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whole blood, serum, white cells, plasma, DNA, Urine
| 12 weeks |
| Hôpital La Pitié Salpêtrière | Active, not recruiting | Paris | 75013 | France |
| Hôpital Bichat-Claude Bernard | Recruiting | Paris | 75018 | France |
|
| CH André Rosemond | Recruiting | Cayenne | 97300 | French Guiana |
|
| CHU de Pointe à Pitre/Abymes | Recruiting | Pointe-à-Pitre | 97261 | Guadeloupe |
|
| Centre Hospitalier Universitaire de Martinique | Recruiting | Fort-de-France | 97200 | Martinique |
|
| CHU de la Réunion | Recruiting | Saint-Denis | 97448 | Reunion |
|
| Centre Hospitalier Gabriel Martin | Recruiting | Saint-Paul | 97866 | Reunion |
|
| Bertolotti A, Thioune M, Abel S, Belrose G, Calmont I, Cesaire R, Cervantes M, Fagour L, Javelle E, Lebris C, Najioullah F, Pierre-Francois S, Roze B, Vigan M, Laouenan C, Cabie A; Chronic Chikungunya working group of University Medical Center of Martinique. Prevalence of chronic chikungunya and associated risks factors in the French West Indies (La Martinique): A prospective cohort study. PLoS Negl Trop Dis. 2020 Mar 12;14(3):e0007327. doi: 10.1371/journal.pntd.0007327. eCollection 2020 Mar. |
| ID | Term |
|---|---|
| D005334 | Fever |
| D003715 | Dengue |
| D065632 | Chikungunya Fever |
| D000071243 | Zika Virus Infection |
| D019595 | Severe Dengue |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D018354 | Alphavirus Infections |
| D014036 | Togaviridae Infections |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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