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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 March 2023
Main ID:  NCT01099852
Date of registration: 23/02/2010
Prospective Registration: Yes
Primary sponsor: University Hospital Center of Martinique
Public title: Cohort of Patients Infected by an Arbovirus CARBO
Scientific title: Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.
Date of first enrolment: June 2010
Target sample size: 1377
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT01099852
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
France French Guiana Guadeloupe Martinique Réunion
Contacts
Name:     Andre Cabie
Address: 
Telephone: 0596552301
Email: andre.cabie@chu-fortdefrance.fr
Affiliation: 
Name:     Andre Cabie, MD
Address: 
Telephone:
Email:
Affiliation:  CHU de Martinique
Key inclusion & exclusion criteria

INCLUSION CRITERIA :

- 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).

EXCLUSION CRITERIA :

- No follow-up possible after the first visit

- Patient or holder of parental authority not registered in the French medical social
security national program



Age minimum: 8 Days
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Dengue
Fever
Zika Virus
Chikungunya
Intervention(s)
Other: Quality of life Questionnaire EuroQol®
Other: Health Assessment Questionnaire - MDHAQ and RAPID3
Other: biological sample collection
Other: Neuropathic Pain Questionnaire (DN4)
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
Secondary ID(s)
09/B/08
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Institut National de la Santé Et de la Recherche Médicale, France
Clinique Antilles-Guyane
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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