NCT01099852

Cohort of Patients Infected by an Arbovirus

Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,377 (estimated)
• Sponsor: University Hospital Center of Martinique · Academic / Other
• Sex: All
• Age: 8 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Hemorrhagic fever (dengue: WHO criteria) * Neurological disorders (West Nile virus infection, Zika virus infection, Japanese encephalitis…) * Chronic chikungunya (persistent Chronic chikungunya (persistent musculoskeletal symptoms for more than three months after symptoms onset)

Conditions

• Fever
• Dengue
• Chikungunya
• Zika Virus

Interventions

Type	Name	Description
OTHER	biological sample collection	blood sample collection urine sample cerebrospinal fluid sample
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.
OTHER	Neuropathic Pain Questionnaire (DN4)	Questionnaire used during the follow up

Timeline

• Start date: 2010-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2010-04-08
• Last updated: 2023-03-16

Locations

8 sites across 5 countries: France, French Guiana, Guadeloupe, Martinique, Reunion