Arbovirus DiseaseARB-OINCT07119086
Factors Associated With Hospitalization and Severity of Arbovirosis in the Indian Ocean
A study testing Biological samples and Questionnaires in people with Arbovirus Disease, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Arboviroses, such as dengue, chikungunya and the Zika virus, represent a growing threat to public health in the Indian Ocean, but also in Europe and the rest of the world. Réunion has experienced several major epidemics, notably chikungunya in 2005-2006 and dengue since 2018, with a current resurgence of chikungunya. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arbovirus Disease
- What is being tested?
- Biological samples and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2025to 5 May 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult, child or newborn > 2.5kg on day of inclusion.
- Use of one of the hospital departments participating in the research, in an emergency room, full hospitalization, day hospitalization or outpatient clinic.
- Suspected, probable or biologically confirmed arbovirosis:
- A suspected case of arbovirosis is defined as :
- asymptomatic contact case of a patient with probable or confirmed arbovirosis
- symptomatic or non-symptomatic newborns of mothers who were viremic for arbovirosis during pregnancy, or who had probable or confirmed arbovirosis during pregnancy.
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- In a patient with a history of a stay in an arbovirus circulation zone in the 2 weeks prior to consultation (for imported cases only).
- In a patient with compatible clinical symptoms during the epidemic period
- A probable case of arbovirosis is defined by :
- the association of at least 2 objectified or reported signs or biology suggestive of arbovirosis: fever (reported by the patient or family, or documented), headache, rash, myalgias, arthralgias, abdominal pain, bleeding, thrombocytopenia, or
- for children under 6: by the reporting (by the family or documented) of a fever on the day of inclusion or in the preceding 7 days, possibly accompanied by pain.
- A biologically confirmed case of arbovirosis is defined by :
- A positive plasma RT-PCR or urine RT-PCR (Zika virus)
- Case 2 : - Retrospectively, patients with sufficiently documented definite, probable or suspected arbovirosis, who give oral consent for their data to be collected retrospectively and/or to continue the study follow-up.
Who cannot join
- 1. Patient ou titulaire de l'autorité parentale non affiliés ou non bénéficiaires d'un régime de sécurité sociale.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
PRCT
Saint-Pierre
BERTOLOTTI, 0262459000, drci@chu-renion.fr
About this study
Arboviroses, such as dengue, chikungunya and the Zika virus, represent a growing threat to public health in the Indian Ocean, but also in Europe and the rest of the world. Réunion has experienced several major epidemics, notably chikungunya in 2005-2006 and dengue since 2018, with a current resurgence of chikungunya. Mayotte was hit by a dengue epidemic in 2019, followed by a few cases of Rift Valley fever. The development of Zika could also affect this region.
Arboviruses, transmitted by hematophagous arthropods, require the coexistence of a reservoir and a vector. Dengue fever, transmitted by Aedes mosquitoes, is caused by four serotypes of dengue virus (DENV) from the orthoflavivirus family. Primary infection with one serotype confers lasting specific immunity, but only transient protection against the other serotypes. Chikungunya, caused by an alphavirus, now causes epidemics in major tropical areas. It is also transmitted by Aedes mosquitoes.
Read more
Arboviruses present four main clinical forms: algoeruptive, hemorrhagic, neurological and arthritic. Dengue fever is 75% asymptomatic, but can progress to a severe form, dengue hemorrhagic fever, characterized by increased vascular permeability and potentially fatal complications. Chikungunya causes a sudden onset of fever, polyarthralgia and maculopapular rash, with possible complications in newborns, the elderly and pregnant women.
Understanding the factors associated with hospitalization and the severity of these infections is crucial to improving patient management and optimizing medical resources. This cohort study aims to identify the clinical, demographic and environmental determinants influencing the severity of arbovirosis. By analyzing data from patients who have used a healthcare facility, we hope to establish risk profiles and severity criteria that may or may not be specific to each infection. The results will enable us to better understand the pathophysiology of these viruses, develop targeted prevention strategies and improve treatment protocols, thereby helping to reduce the morbidity and mortality associated with arboviroses in this region.
Due to the current chikungunya epidemic in La Réunion, this study will focus on the inclusion of patients affected by this arbovirosis as early as 2025. Its openness over the coming years will allow sufficient reactivity to include any arbovirosis on the territories of Mayotte and La Réunion.
- Conditions
- Arbovirus Disease
- Being tested
- Biological samples, Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesBiological
Blood and urine samples
QuestionnairesOther
Quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| All patient with | Other | Blood samples and questionnaires Receives: Biological: Biological samples; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a severe form of arbovirosis
Occurrence of a severe form of arbovirosis: shock, internal hemorrhage, severe organ failure (visceral, cardiac, neurological, ophthalmological, renal, pulmonary, hepatic, etc.), death caused directly or indirectly by the infection.
Measured: THROUGHT STUDY COMPLETION AN AVERAGE OF 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start2 Jun 2025
- Primary completion5 May 2037 (estimated)
- Study completion5 May 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119086
- Sponsor's protocol ID
- 2025/CHU/03
- Other IDs
- ID-RCB
- Acronym
- ARB-OI
- Status last verified
- Sep 2026
- First submitted
- 5 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Hospitalization and Severity of Arbovirosis in the Indian Ocean
- ClinicalTrials.gov ID
- NCT07119086
- Acronym / sponsor ID
- ARB-OI / 2025/CHU/03
- Conditions
- Arbovirus Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 5 May 2037 (estimated)
- Study completion
- 5 May 2037 (estimated)
- First posted
- 12 Aug 2025 (actual)
- 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.
Arboviroses, such as dengue, chikungunya and the Zika virus, represent a growing threat to public health in the Indian Ocean, but also in Europe and the rest of the world. Réunion has experienced several major epidemics, notably chikungunya in 2005-2006 and dengue since 2018, with a current resurgence of chikungunya. Mayotte was hit by a dengue epidemic in 2019, followed by a few cases of Rift Valley fever. The development of Zika could also affect this region.
Arboviruses, transmitted by hematophagous arthropods, require the coexistence of a reservoir and a vector. Dengue fever, transmitted by Aedes mosquitoes, is caused by four serotypes of dengue virus (DENV) from the orthoflavivirus family. Primary infection with one serotype confers lasting specific immunity, but only transient protection against the other serotypes. Chikungunya, caused by an alphavirus, now causes epidemics in major tropical areas. It is also transmitted by Aedes mosquitoes.
Arboviruses present four main clinical forms: algoeruptive, hemorrhagic, neurological and arthritic. Dengue fever is 75% asymptomatic, but can progress to a severe form, dengue hemorrhagic fever, characterized by increased vascular permeability and potentially fatal complications. Chikungunya causes a sudden onset of fever, polyarthralgia and maculopapular rash, with possible complications in newborns, the elderly and pregnant women.
Understanding the factors associated with hospitalization and the severity of these infections is crucial to improving patient management and optimizing medical resources. This cohort study aims to identify the clinical, demographic and environmental determinants influencing the severity of arbovirosis. By analyzing data from patients who have used a healthcare facility, we hope to establish risk profiles and severity criteria that may or may not be specific to each infection. The results will enable us to better understand the pathophysiology of these viruses, develop targeted prevention strategies and improve treatment protocols, thereby helping to reduce the morbidity and mortality associated with arboviroses in this region.
Due to the current chikungunya epidemic in La Réunion, this study will focus on the inclusion of patients affected by this arbovirosis as early as 2025. Its openness over the coming years will allow sufficient reactivity to include any arbovirosis on the territories of Mayotte and La Réunion.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patient with | Other | Biological: Biological samples, Other: QuestionnairesBlood samples and questionnaires |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Adult, child or newborn > 2.5kg on day of inclusion.
- Use of one of the hospital departments participating in the research, in an emergency room, full hospitalization, day hospitalization or outpatient clinic.
- Suspected, probable or biologically confirmed arbovirosis:
- asymptomatic contact case of a patient with probable or confirmed arbovirosis
- symptomatic or non-symptomatic newborns of mothers who were viremic for arbovirosis during pregnancy, or who had probable or confirmed arbovirosis during pregnancy.
Key exclusion criteria (1 listed)
- 1. Patient ou titulaire de l'autorité parentale non affiliés ou non bénéficiaires d'un régime de sécurité sociale.
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 samplesBlood and urine samples | Biological | All patient with |
| QuestionnairesQuality of life questionnaires | Other | All patient with |
Primary outcome
Occurrence of a severe form of arbovirosis
Time frame: THROUGHT STUDY COMPLETION AN AVERAGE OF 3 YEARS
Occurrence of a severe form of arbovirosis: shock, internal hemorrhage, severe organ failure (visceral, cardiac, neurological, ophthalmological, renal, pulmonary, hepatic, etc.), death caused directly or indirectly by the infection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples and Questionnaires in people with Arbovirus Disease, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 14 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHU La Réunion DRCI (0262717885, melanie.begorre@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a severe form of arbovirosis (time frame: THROUGHT STUDY COMPLETION AN AVERAGE OF 3 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.