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Cohort of Patients Infected by an Arbovirus (CARBO)

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ClinicalTrials.gov Identifier: NCT01099852
Recruitment Status : Recruiting
First Posted : April 8, 2010
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:

Arbovirus refers to a group of viruses transmitted by blood-feeding arthropods. There are hundred which have been shown to cause disease in humans. The incubation period is usually limited between 1 and 15 days. The most common clinical features of infection are 4: algo-eruptive, hemorrhagic fever, neurological or arthritic afflictions.

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 after 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 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 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.

Since the early 2000s, the French West Indies and French Guiana have become hyperendemic for dengue with simultaneous circulation of the 4 serotypes, regular large outbreak 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 were described in French Antilles in Nov. 2013. The disease 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 4 to 6 weeks. However, severe clinical forms in early stage 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 they may cause outbreaks with specific severe clinical complications. French interministerial mission on emerging infectious diseases, coordinated by Professor A. Flahault, recommended such studies.


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

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)

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Study Type : Observational
Estimated Enrollment : 1377 participants
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
Study Start Date : June 2010
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021



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.


Primary Outcome Measures :
  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. [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  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) [ Time Frame: 12 weeks ]

    The analysis will focus only on patients with biologically confirmed arbovirosis by one of the following exams:

    • RT-PCR plasma (arbovirus), or urine (Zika virus),
    • Research of the NS1 positive antigen (dengue),
    • Significant appearance or increase of the G immunoglobulin directed against the arbovirus in question between an early serum (during the first week following the onset of symptoms) and another taken at least 10 days later


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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099852


Contacts
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Contact: Andre Cabie 0596552301 andre.cabie@chu-fortdefrance.fr

Locations
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France
Hôpital Bichat-Claude Bernard Recruiting
Paris, France, 75018
Contact: Sophie MATHERON, MD    01 40 25 78 83    Sophie.matheron@bch.ah-hop-paris.fr   
French Guiana
CH André Rosemond Recruiting
Cayenne, French Guiana, 97300
Contact: Félix Djossou, MD       felix.djossou@ch-cayenne.fr   
Principal Investigator: Félix Djossou, MD         
Guadeloupe
CHU de Pointe à Pitre/Abymes Recruiting
Pointe à Pitre, Guadeloupe, 97261
Contact: Kinda SCHEPPERS, MD    05 90 89 15 89    kinda.schepers@chu-guadeloupe.fr   
Martinique
Centre Hospitalier Universitaire de Martinique Recruiting
Fort-de-France, Martinique, 97200
Contact: Janick Jean-Marie    592697 ext 0596    janick.jean-marie@chu-martinique.fr   
Contact: Isabelle Calmont    592697 ext 0596    isabelle.calmont@chu-martinique.fr   
Principal Investigator: André Cabié, MD         
Sponsors and Collaborators
University Hospital Center of Martinique
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Investigators
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Principal Investigator: Andre Cabie, MD CHU de Martinique

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT01099852     History of Changes
Other Study ID Numbers: 09/B/08
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital Center of Martinique:
dengue
fever
dengue hemorrhagic fever
dengue virus
Chikungunya virus
Zika Virus
Joint pain
Additional relevant MeSH terms:
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Dengue
Chikungunya Fever
Zika Virus Infection
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Alphavirus Infections
Togaviridae Infections