NCT07119086

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
134mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jun 2025May 2037

First Submitted

Initial submission to the registry

May 5, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2037

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

11.9 years

First QC Date

May 5, 2025

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    THROUGHT STUDY COMPLETION AN AVERAGE OF 3 YEARS

Study Arms (1)

All patient with

OTHER

Blood samples and questionnaires

Biological: Biological samplesOther: Questionnaires

Interventions

Blood and urine samples

All patient with

Quality of life questionnaires

All patient with

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • 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.

You may not qualify if:

  • \. Patient ou titulaire de l'autorité parentale non affiliés ou non bénéficiaires d'un régime de sécurité sociale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRCT

Saint-Pierre, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

CHU La Réunion DRCI

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2025

First Posted

August 12, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

May 5, 2037

Study Completion (Estimated)

May 5, 2037

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations