Status:
COMPLETED
Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Lead Sponsor:
Centre Hospitalier Universitaire de la Réunion
Conditions:
Leptospirosis
Eligibility:
All Genders
4+ years
Phase:
NA
Brief 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-alveo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05413720
Start Date
January 6 2021
End Date
July 20 2022
Last Update
October 25 2023
Active Locations (4)
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1
GHER
Saint-Benoît, Reunion, 97470
2
CHU de la Réunion
Saint-Denis, Reunion, 97400
3
CHOR
Saint-Paul, Reunion, 97460
4
CHU de la Réunion
Saint-Pierre, Reunion, 97448