DengueMAIDENNCT05852977
Study of Dengue in Patients With Autoimmune Diseases During the Epidemics of 2020 and 2021 in Reunion Island
An observational study of Dengue, run by Centre Hospitalier Universitaire de la Réunion.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- minor
- opposition to the re-use of data
- patient not followed in Reunion
- protected adult (guardianship or curatorship) or under legal protection
Trial locations and contacts
No sites are listed yet.
Marie PERROT contact
About this study
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
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).
- Conditions
- Dengue
- Medical subject headings
- Dengue
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc RAFFRAY, MD, Principal investigator, CHU de la Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852977
- Sponsor's protocol ID
- 2022/CHU/24
- Acronym
- MAIDEN
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05852977
- Acronym / sponsor ID
- MAIDEN / 2022/CHU/24
- Conditions
- Dengue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 May 2023 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- minor
- opposition to the re-use of data
- patient not followed in Reunion
- protected adult (guardianship or curatorship) or under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the observed severity of dengue in patients with autoimmune/autoinflammatory diseases.
Time frame: Day 1
Proportion of severe dengue (WHO 2009 definition) in patients with autoimmune/autoinflammatory disease who contracted dengue in 2020/2021, with 95% confidence interval (CI95%).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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. This study is not recruiting at the moment.
Marie PERROT contact
Loïc RAFFRAY, MD principal investigator
CHU de la Réunion
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Centre Hospitalier Universitaire de la Réunion.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loïc RAFFRAY, MD (0262 90 54 50, loic.raffray@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the observed severity of dengue in patients with autoimmune/autoinflammatory diseases. (time frame: Day 1). 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 10 May 2023.