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NCT05852977 Clinical Trial

Study of Dengue in Patients With Autoimmune Diseases During the Epidemics of 2020 and 2021 in Reunion Island

Dengue Clinical Trial

— MAIDEN  

Official title:
Study of Dengue in Patients With Autoimmune Diseases With or Without Immunosuppressive Treatment During the Epidemics of 2020 and 2021 in Reunion Island

Clinical Trial Details — Status: Not yet recruiting

Administrative data
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

Study information
Verified date May 2023
Source Centre Hospitalier Universitaire de la Réunion
Contact Loïc RAFFRAY, MD
Phone 0262 90 54 50
Email loic.raffray@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome
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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