NCT05852977

Brief Summary

It is not known whether there is a different clinical profile of dengue in patients with immune system dysfunction. Preliminary data and previous literature suggest that autoimmune diseases, and in particular their treatment, may favour the evolution to severe forms of dengue. Our research hypothesis is that the clinico-biological presentation of dengue might be different in case of autoimmune disease, either on the side of overactivation (autoimmune and auto inflammatory diseases without treatment) or immunodepression (autoimmune and auto inflammatory diseases under immunosuppressive treatment).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2023

Typical duration for all trials

Status
not yet 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 Progress98%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

May 2, 2023

Last Update Submit

May 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the observed severity of dengue in patients with autoimmune/autoinflammatory diseases.

    Proportion of severe dengue (WHO 2009 definition) in patients with autoimmune/autoinflammatory disease who contracted dengue in 2020/2021, with 95% confidence interval (CI95%).

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with systemic autoimmune disease who have contracted a proven episode of dengue in 2020-21. Only patients followed up at the University Hospital of La Reunion or the Centre Hospitalier Ouest Reunion (CHOR), with or without immunosuppressive treatment will be selected.

You may qualify if:

  • Age ≥18 years
  • Patient with autoimmune or autoinflammatory disease
  • Confirmed diagnosis of dengue (in 2020 or 2021): serological test, antigenic test or PCR test to confirm the diagnosis according to current criteria

You may not qualify if:

  • minor
  • opposition to the re-use of data
  • patient not followed in Reunion
  • protected adult (guardianship or curatorship) or under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Loïc RAFFRAY, MD

    CHU de la Réunion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie PERROT

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share