FeverCARBONCT01099852
Cohort of Patients Infected by an Arbovirus
An observational study of Fever and Dengue, run by University Hospital Center of Martinique at 8 sites in 5 countries.
Trial summary
There are hundred of arbovirus which have been shown to cause disease in humans. Their most common clinical symptoms are algo-eruptive (dengue, chikungunya, zika), hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West Nile, Zika, dengue, Japanese encephalitis) or arthritic… Read more about this study
- Who is it for?
- Ages 8 days and older
- Conditions the study is for
- Fever, Dengue, Chikungunya
- What is being tested?
- biological sample collection, Quality of life Questionnaire EuroQol® and Health Assessment Questionnaire - MDHAQ and RAPID3
- How many people
- 1,377 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Jun 2010to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital cohort of children and adults with suspected of infectious by an arbovirus in the overseas departments and regions and in France.
Who may be able to join
- 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).
Who cannot join
- No follow-up possible after the first visit
- Patient or holder of parental authority not registered in the French medical social security national program
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
France3 sites, 2 recruiting
- Recruiting
Hôpital Saint André
Bordeaux, 33000
Jean-Marie Denis MALVY, 05.57.82.22.20, denis.malvy@chu-bordeaux.fr
- Active, not recruiting
Hôpital La Pitié Salpêtrière
Paris, 75013
- Recruiting
Hôpital Bichat-Claude Bernard
Paris, 75018
Sophie MATHERON, MD, 01 40 25 78 83, Sophie.matheron@bch.ah-hop-paris.fr
Reunion2 sites, 2 recruiting
- Recruiting
CHU de la Réunion
Saint-Denis, 97448
Antoine BERTOLOTTI, 02 62 35 91 65, antoine_bertolotti@yahoo.fr
- Recruiting
Centre Hospitalier Gabriel Martin
Saint-Paul, 97866
Rémi GIRERD, 0262453030, remigirerd@gmail.com
French Guiana1 site, 1 recruiting
- Recruiting
CH André Rosemond
Cayenne, 97300
Félix Djossou, MD, felix.djossou@ch-cayenne.fr
Félix Djossou, MD
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU de Pointe à Pitre/Abymes
Pointe-à-Pitre, 97261
Adeline MALLARD, 05 90 89 10 10, adeline.mallard@chu-guadeloupe.fr
Martinique1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Martinique
Fort-de-France, 97200
Janick Jean-Marie, 592697 ext. 0596, janick.jean-marie@chu-martinique.fr
Isabelle Calmont, 592697 ext. 0596, isabelle.calmont@chu-martinique.fr
About this study
Official title: Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.
There are hundred of arbovirus which have been shown to cause disease in humans. Their most common clinical symptoms are algo-eruptive (dengue, chikungunya, zika), hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West Nile, Zika, dengue, Japanese encephalitis) or arthritic afflictions (Chikungunya, O'nyong nyong). 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 in 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 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 forms is also poorly known. Since 2000s, the French West Indies and Guiana have become hyperendemic for dengue with simultaneous circulation of the 4 serotypes, regular large outbreaks and severe dengue including fatalities. Chikungunya is a re-emerging virus 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 typically consists of an acute illness like dengue fever with abrupt onset of a high-grade fever followed by constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves in 4 to 6 weeks. However, severe clinical forms in early stage may appear and chronic clinical forms as incapacitating arthralgia which affect 40 to 60% of patients. 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. The French interministerial mission on emerging infectious diseases coordinated by Professor Antoine Flahault, recommended such studies: large prospective multicenter cohort studies to characterize severe forms of arbovirus infections to seek predictive factors and to investigate the pathophysiology of the diseases.
Read the 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 Chronic chikungunya (persistent musculoskeletal symptoms for more than three months after symptoms onset)
- Conditions
- Fever, Dengue, Chikungunya, Zika Virus
- Being tested
- biological sample collection, Quality of life Questionnaire EuroQol®, Health Assessment Questionnaire - MDHAQ and RAPID3, Neuropathic Pain Questionnaire (DN4)
- Keywords
- dengue, fever, dengue hemorrhagic fever, dengue virus, Chikungunya virus, Zika Virus, Joint pain
- Medical subject headings
- Fever, Dengue, Chikungunya Fever, Zika Virus Infection, Severe Dengue, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological sample collectionOther
blood sample collection urine sample cerebrospinal fluid sample
Quality of life Questionnaire EuroQol®Other
Changes in quality of life, measured with the EuroQol® questionnaire 3 and 12 weeks after the onset of dengue fever symptoms.
Health Assessment Questionnaire - MDHAQ and RAPID3Other
Questionnaire used at the 3rd month of follow up.
Neuropathic Pain Questionnaire (DN4)Other
Questionnaire used during the follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 12 weeks
Secondary outcomes (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)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,377 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Clinique Antilles-Guyane
- Responsible party
- Sponsor
- Investigators
- Andre Cabie, MD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099852
- Sponsor's protocol ID
- 09/B/08
- Acronym
- CARBO
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2010
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Carras M, Maillard O, Cousty J, Gerardin P, Boukerrou M, Raffray L, Mavingui P, Poubeau P, Cabie A, Bertolotti A. Associated risk factors of severe dengue in Reunion Island: A prospective cohort study. PLoS Negl Trop Dis. 2023 Apr 17;17(4):e0011260. doi: 10.1371/journal.pntd.0011260. eCollection 2023 Apr.
PubMed 37068115Bertolotti A, Thioune M, Abel S, Belrose G, Calmont I, Cesaire R, Cervantes M, Fagour L, Javelle E, Lebris C, Najioullah F, Pierre-Francois S, Roze B, Vigan M, Laouenan C, Cabie A; Chronic Chikungunya working group of University Medical Center of Martinique. Prevalence of chronic chikungunya and associated risks factors in the French West Indies (La Martinique): A prospective cohort study. PLoS Negl Trop Dis. 2020 Mar 12;14(3):e0007327. doi: 10.1371/journal.pntd.0007327. eCollection 2020 Mar.
PubMed 32163420
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.
- ClinicalTrials.gov ID
- NCT01099852
- Acronym / sponsor ID
- CARBO / 09/B/08
- Conditions
- Fever, Dengue, Chikungunya, Zika Virus
- Keywords
- dengue, fever, dengue hemorrhagic fever, dengue virus, Chikungunya virus, Zika Virus, Joint pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,377 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Clinique Antilles-Guyane
- Study start
- Jun 2010 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are hundred of arbovirus which have been shown to cause disease in humans. Their most common clinical symptoms are algo-eruptive (dengue, chikungunya, zika), hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West Nile, Zika, dengue, Japanese encephalitis) or arthritic afflictions (Chikungunya, O'nyong nyong). 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 in 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 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 forms is also poorly known. Since 2000s, the French West Indies and Guiana have become hyperendemic for dengue with simultaneous circulation of the 4 serotypes, regular large outbreaks and severe dengue including fatalities. Chikungunya is a re-emerging virus 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 typically consists of an acute illness like dengue fever with abrupt onset of a high-grade fever followed by constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves in 4 to 6 weeks. However, severe clinical forms in early stage may appear and chronic clinical forms as incapacitating arthralgia which affect 40 to 60% of patients. 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. The French interministerial mission on emerging infectious diseases coordinated by Professor Antoine Flahault, recommended such studies: large prospective multicenter cohort studies to characterize severe forms of arbovirus infections to seek predictive factors and to investigate the pathophysiology of the diseases.
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 Chronic chikungunya (persistent musculoskeletal symptoms for more than three months after symptoms onset)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital cohort of children and adults with suspected of infectious by an arbovirus in the overseas departments and regions and in France.
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (2 listed)
- No follow-up possible after the first visit
- Patient or holder of parental authority not registered in the French medical social security national program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological sample collectionblood sample collection urine sample cerebrospinal fluid sample | 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 RAPID3Questionnaire used at the 3rd month of follow up. | Other | – |
| Neuropathic Pain Questionnaire (DN4)Questionnaire used during the follow up | Other | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 37068115Carras M, Maillard O, Cousty J, Gerardin P, Boukerrou M, Raffray L, Mavingui P, Poubeau P, Cabie A, Bertolotti A. Associated risk factors of severe dengue in Reunion Island: A prospective cohort study. PLoS Negl Trop Dis. 2023 Apr 17;17(4):e0011260. doi: 10.1371/journal.pntd.0011260. eCollection 2023 Apr.
- Derived from this study: PubMed 32163420Bertolotti A, Thioune M, Abel S, Belrose G, Calmont I, Cesaire R, Cervantes M, Fagour L, Javelle E, Lebris C, Najioullah F, Pierre-Francois S, Roze B, Vigan M, Laouenan C, Cabie A; Chronic Chikungunya working group of University Medical Center of Martinique. Prevalence of chronic chikungunya and associated risks factors in the French West Indies (La Martinique): A prospective cohort study. PLoS Negl Trop Dis. 2020 Mar 12;14(3):e0007327. doi: 10.1371/journal.pntd.0007327. eCollection 2020 Mar.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Cabie, MD principal investigator
CHU de Martinique
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Dengue, run by University Hospital Center of Martinique at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Reunion, French Guiana, Guadeloupe, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andre Cabie (0596552301, andre.cabie@chu-fortdefrance.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01099852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.