Molecular and Cellular Basis of Severe Forms of Dengue in Sickle Cell Patients (NCT07000747) | Clinical Trial Compass
RecruitingNot Applicable
Molecular and Cellular Basis of Severe Forms of Dengue in Sickle Cell Patients
Guadeloupe130 participantsStarted 2024-06-24
Plain-language summary
Dengue virus (DENV) belongs to the genus of Flavivirus transmitted by the mosquito Aedes aegypti and is responsible for an infectious disease associated with different forms and severities such as dengue hemorrhagic fever or shock syndrome. Several recent reports have shown that sickle cell patients exhibited an increased risk of developing severe forms of dengue episodes compared to non-sickle cell subjects. Furthermore, among major sickle cell syndromes, these studies suggest that SC patients are at the highest risk of death during these infectious episodes although this sickle cell syndrome is generally associated with a more moderate expression of sickle cell disease. However, the mechanisms involved remain unknown to date.
The aim of the present study is to identify the molecular and cellular basis of this increased severity of dengue in SC patients. We hypothesize an exacerbation during DENV infection of the inflammatory response in SC patients compared to SS patients.
Who can participate
Age range
6 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with SS or SC SCD or controls with hemoglobin AA
* diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
* patients older than 6 years and younger than 25 at inclusion
* clinically in a steady state at inclusion (without complication during the last month and without transfusion in the three last months)
* patients followed up for SCD at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe-à-Pitre)
* patients or legal representatives of minors who will provide written informed consent in accordance with the Declaration of Helsinki
* patients affiliated to national social security
* the control group (AA subjects) will be recruited among volunteers recruited by posters
Exclusion Criteria:
* patients with SS or SC SCD or controls with hemoglobin AA
* diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
* patients older than 6 years and younger than 25 at inclusion
* clinically in a steady state at inclusion (without complication during the last month and without transfusion in the three last months)
* patients followed up for SCD at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe-à-Pitre)
* patients or legal representatives of minors who will provide written informed consent in accordance with the Declaration of Helsinki
* patients affiliated to national social security
* the control group…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lymphocyte subpopulations measured by flow cytometry at steady-state
Timeframe: baseline
Trial details
NCT IDNCT07000747
SponsorCentre Hospitalier Universitaire de la Guadeloupe