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Fever | Cohort of Patients Infected by an Arbovirus

Fever research study

What is the primary objective of this study?

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 .

Who is eligible to participate?

INCLUSION CRITERIA : 1. Adult, child or newborn. 2. Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit). 3. Arbovirosis suspected or confirmed biologically: A suspected case of arbovirus infection is defined by: - The combination of clinical and biological signs observed on the day of enrollment or during the previous 7 days: fever (reported by the patient or family, or documented) and two or more of the following signs: 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 greater than or equal to 4/10 on hetero assessment scale age age-appropriate 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.. 4. Symptom onset within the seven days before the enrollment visit or within 21 days for severe forms of the disease.Possibility of follow-up throughout study period. 5. Patient or holder of parental authority registered in the French medical social security national program 6. 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). EXCLUSION CRITERIA : 1. Newborn with a weight < 2.5 kg the days of enrollment 2. Suspected arbovirosis whose symptom onset date more than 7 days or 21 days for severe forms of the disease.Clinical diagnosis of another infection as arbovirosis 3. Confirmed Malaria Access 4. No follow-up possible after the first visit 5. Refusal to participate to the study 6. Patient or holder of parental authority not registered in the French medical social security national program

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fever

Dengue

Chikungunya

Zika Virus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:biological sample collectionblood 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 RAPID3Questionnaire used at the 3rd month of follow up.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: June 2010

Completed Date: July 2021

Phase:

Type: Observational

Design:

Primary Outcome: 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.

Secondary Outcome: 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.

Study sponsors, principal investigator, and references

Principal Investigator: Andre Cabie, MD

Lead Sponsor: University Hospital Center of Martinique

Collaborator: Institut National de la Santé Et de la Recherche Médicale, France

More information:https://clinicaltrials.gov/show/NCT01099852

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