Main
|
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: |
|
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]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|