Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO (NCT05413720) | Clinical Trial Compass
CompletedNot Applicable
Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Reunion100 participantsStarted 2021-01-06
Plain-language summary
The research hypothesis is based on a suspected strong involvement of the immune system in the genesis of serious manifestations of the disease (hepatitis, renal failure, thrombocytopenia, intra-alveolar hemorrhage). The question asked is that of the state of the immune system (quantitative and qualitative: activation markers, production of cytokines) evaluated by the study of circulating innate immune cells (monocytes, neutrophils, dendritic cells, lymphocytes, platelets).
Who can participate
Age range
4 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:
* Age ≥ 4 years;
* Weight ≥ 11 kg;
* with ongoing symptoms compatible with a clinical diagnosis of leptospirosis.
* AND having a diagnosis of leptospirosis confirmed according to standard care procedures: preferably by Polymerase Chain Reaction (PCR) (blood or urine) or, failing that, serology indicating a recent infection (positive Immunoglobulin M (IgM) or Microscopic Agglutination Test (MAT) technique with titer \>1/400 for a pathogenic serogroup)
* AND affiliated to a Social Security scheme
Exclusion Criteria:
* Refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.).
* Not affiliated with social security
* Immunosuppression that may interfere with the interpretation of the results: chemotherapy in progress, immunosuppressants in progress for organ transplantation or autoimmune disease
* Patient under legal protection (Guardianship, Curators)
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
proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes
Timeframe: at inclusion
Trial details
NCT IDNCT05413720
SponsorCentre Hospitalier Universitaire de la Réunion