Cohort of Patients Infected by an Arbovirus

NCT01099852 | Unknown DMC

• 1 other identifier: 09/B/08
• Study Type: observational
• Target: 1,377
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

Fever; Dengue; Chikungunya; Zika Virus

Keywords

dengue; fever; dengue hemorrhagic fever; dengue virus; Chikungunya virus; Zika Virus; Joint pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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)

  12 weeks

Interventions

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

Eligibility Criteria

• Age: 8 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital cohort of children and adults with suspected of infectious by an arbovirus in the overseas departments and regions and in France.

You may qualify if:

• 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).

You may not qualify if:

• No follow-up possible after the first visit
• Patient or holder of parental authority not registered in the French medical social security national program

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Clinique Antilles-Guyane: collaborator

Study Sites (8)

Hôpital Saint André

Bordeaux, 33000, France

RECRUITING

Hôpital La Pitié Salpêtrière

Paris, 75013, France

ACTIVE NOT RECRUITING

Hôpital Bichat-Claude Bernard

Paris, 75018, France

RECRUITING

CH André Rosemond

Cayenne, 97300, French Guiana

RECRUITING

CHU de Pointe à Pitre/Abymes

Pointe-à-Pitre, 97261, Guadeloupe

RECRUITING

Centre Hospitalier Universitaire de Martinique

Fort-de-France, 97200, Martinique

RECRUITING

CHU de la Réunion

Saint-Denis, 97448, Reunion

RECRUITING

Centre Hospitalier Gabriel Martin

Saint-Paul, 97866, Reunion

RECRUITING

Related Publications (2)

• 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.

  PMID: 37068115 DERIVED

• 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.

  PMID: 32163420 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, plasma, DNA, Urine

MeSH Terms

Conditions

Fever; Dengue; Chikungunya Fever; Zika Virus Infection; Severe Dengue; Arthralgia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations

Study Officials

• Andre Cabie, MD

  CHU de Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre Cabie

CONTACT

0596552301; andre.cabie@chu-fortdefrance.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: April 8, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-02

Locations

RE (2); FR (1); GU (1); MA (1)