Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO

Centre Hospitalier Universitaire de la Réunion3 sites in 1 country100 target enrollmentJanuary 6, 2021

ConditionsLeptospirosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Leptospirosis
Sponsor: Centre Hospitalier Universitaire de la Réunion
Enrollment: 100
Locations: 3
Primary Endpoint: proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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-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).

Registry

clinicaltrials.gov

Start Date

January 6, 2021

End Date

July 20, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de la Réunion

Responsible Party

Sponsor

Eligibility Criteria

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)