NCT07000747 Molecular and Cellular Basis of Severe Forms of Dengue in Sickle Cell Patients
| NCT ID | NCT07000747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de la Guadeloupe |
| Condition | Dengue (Virus); Fever, Sandfly |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2026-06-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2024-06-24 with a primary completion date of 2026-06-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 (AA subjects) will be recruited among volunteers recruited by posters
Contact & Investigator
Maryse Etienne-Julan, MD PhD
PRINCIPAL INVESTIGATOR
CHU de la Guadeloupe
Frequently Asked Questions
Who can join the NCT07000747 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 25 Years, studying Dengue (Virus); Fever, Sandfly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07000747 currently recruiting?
Yes, NCT07000747 is actively recruiting participants. Contact the research team at valerie.soter@chu-guadeloupe.fr for enrollment information.
Where is the NCT07000747 trial being conducted?
This trial is being conducted at Pointe-à-Pitre, Guadeloupe.
Who is sponsoring the NCT07000747 clinical trial?
NCT07000747 is sponsored by Centre Hospitalier Universitaire de la Guadeloupe. The principal investigator is Maryse Etienne-Julan, MD PhD at CHU de la Guadeloupe. The trial plans to enroll 130 participants.