Cohort of Patients Infected by an Arbovirus (CARBO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Centre Hospitalier Universitaire de Fort-de-France
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01099852
First received: February 23, 2010
Last updated: February 29, 2016
Last verified: February 2016
  Purpose

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 .


Condition Intervention
Fever
Dengue
Chikungunya
Zika
Other: biological sample collection
Other: quality of life questionnaire EuroQol®
Other: Health Assessment Questionnaire - MDHAQ and RAPID3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.r

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells, plasma, DNA, Urine

Estimated Enrollment: 3000
Study Start Date: June 2010
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: biological sample collection
    blood 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 RAPID3
    Questionnaire used at the 3rd month of follow up.
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 musculoskeletal symptoms for more than three months after symptoms onset)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital cohort of children and adults with suspected of infectious by an arbovirus in French.
Criteria

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).

NON INCLUSION 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099852

Locations
France
CH André Rosemond Recruiting
Cayenne, Guiana, France, 97300
Contact: Félix Djossou, MD       felix.djossou@ch-cayenne.fr   
Principal Investigator: Félix Djossou, MD         
Centre Hospitalier Universitaire de Fort-de-France Recruiting
Fort-de-France, Martinique, France, 97200
Contact: Janick Jean-Marie    592697 ext 0596    janick.jean-marie@chu-fortdefrance.fr   
Contact: Paul Mourlhou    592697 ext 0596    paul.mourlhou@chu-fortdefrance.fr   
Principal Investigator: André Cabié, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
  More Information

Responsible Party: Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier: NCT01099852     History of Changes
Other Study ID Numbers: 09/B/08 
Study First Received: February 23, 2010
Last Updated: February 29, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
dengue
fever
dengue hemorrhagic fever
dengue virus
Chikungunya virus
Zika Virus
Joint pain

ClinicalTrials.gov processed this record on May 04, 2016