Dengue Clinical Trial
— MAIDENOfficial title:
Study of Dengue in Patients With Autoimmune Diseases With or Without Immunosuppressive Treatment During the Epidemics of 2020 and 2021 in Reunion Island
| NCT number | NCT05852977 |
| Other study ID # | 2022/CHU/24 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2023 |
| Est. completion date | June 2026 |
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).
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | June 2026 |
| Est. primary completion date | June 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - minor - opposition to the re-use of data - patient not followed in Reunion - protected adult (guardianship or curatorship) or under legal protection |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de la Réunion |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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