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

NCT ID: NCT05413720

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2022-07-20

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).

Conditions

Leptospirosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with leptospirosis

Group Type: OTHER

two additional blood samples specific to research

Intervention Type: OTHER

proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes in the acute phase

Interventions

two additional blood samples specific to research

proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes in the acute phase

Intervention Type: OTHER

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)

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GHER

Saint-Benoît, , Reunion

CHU de la Réunion

Saint-Denis, , Reunion

CHOR

Saint-Paul, , Reunion

CHU de la Réunion

Saint-Pierre, , Reunion

Countries

Reunion

Other Identifiers

2017/CHU/14

Identifier Type: -

Identifier Source: org_study_id