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

Trial Information
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Healthy Volunteers:
No

• 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:

• The combination of clinical and biological signs observed suggestive of arbovirosus infection: fever (reported by the patient or family, or documented), headache, rash, myalgia, arthralgia, abdominal pain, hemorrhage, thrombocytopenia, or

• Children under 6 years: the report (by family or documented) of a fever on the day of enrollment or within 7 previous days, possibly accompanied by a of pain - At a patient with a notion of stay in 2 weeks preceding in a zone of arbovirus circulation (only for the imported cases)

• A case of arbovirus infection confirmed biologically is defined by:

• RT-PCR arbovirus positive in plasma or urine (Zika virus infection), or by detection of the NS1 antigen (dengue), or an appearance or an significant increase (multiplication of the title by four) of the G immunoglobulin directed against arbovirus in question on an early taken serum (during the first week following the start of symptoms) and another taken at least 10 days later.

• Symptom onset within the 7 days before the enrollment visit or within 21 days for severe forms of the disease.Possibility of follow-up throughout study period. * 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).

Where is this trial taking place?
Other Locations
France
Hôpital Saint André
Recruiting
Bordeaux
Hôpital Bichat-Claude Bernard
Recruiting
Paris
Hôpital La Pitié Salpêtrière
Active, not recruiting
Paris
French Guiana
CH André Rosemond
Recruiting
Cayenne
Guadeloupe
CHU de Pointe à Pitre/Abymes
Recruiting
Pointe À Pitre
Martinique
Centre Hospitalier Universitaire de Martinique
Recruiting
Fort-de-france
Réunion
CHU de la Réunion
Recruiting
Saint-denis
Centre Hospitalier Gabriel Martin
Recruiting
Saint-paul
Who do I contact about this trial?
Primary
Andre Cabie
andre.cabie@chu-fortdefrance.fr
0596552301
When is this trial taking place?
Start Date: June 2010
Estimated Completion Date: July 2021
How many participants will be in this trial?
Target number of participants: 1377
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov