Leptospirosis Clinical Trial
— IMMUNOLEPTOOfficial title:
Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Verified date | August 2023 |
Source | Centre Hospitalier Universitaire de la Réunion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 100 |
Est. completion date | July 20, 2022 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Réunion | GHER | Saint-Benoît | |
Réunion | CHU de la Réunion | Saint-Denis | |
Réunion | CHOR | Saint-Paul | |
Réunion | CHU de la Réunion | Saint-Pierre |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de la Réunion |
Réunion,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes | at inclusion |
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