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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

Tracking Information
First Submitted Date February 23, 2010
First Posted Date April 8, 2010
Last Update Posted Date July 24, 2019
Study Start Date June 2010
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2019)
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.
Original Primary Outcome Measures
 (submitted: April 6, 2010)
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 ]
Change History Complete list of historical versions of study NCT01099852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 22, 2019)
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
Original Secondary Outcome Measures
 (submitted: April 6, 2010)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cohort of Patients Infected by an Arbovirus
Official Title Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.r
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.

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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, white cells, plasma, DNA, Urine
Sampling Method Non-Probability Sample
Study Population Hospital cohort of children and adults with suspected of infectious by an arbovirus in French.
Condition
  • Fever
  • Dengue
  • Chikungunya
  • Zika Virus
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 26, 2016)
1377
Original Estimated Enrollment
 (submitted: April 6, 2010)
3000
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Andre Cabie 0596552301 andre.cabie@chu-fortdefrance.fr
Listed Location Countries France,   French Guiana,   Guadeloupe,   Martinique
Removed Location Countries  
 
Administrative Information
NCT Number NCT01099852
Other Study ID Numbers 09/B/08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital Center of Martinique
Study Sponsor University Hospital Center of Martinique
Collaborators
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Clinique Antilles-Guyane
Investigators
Principal Investigator: Andre Cabie, MD CHU de Martinique
PRS Account University Hospital Center of Martinique
Verification Date January 2019