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

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).

Study Overview

• Status: Completed
• Conditions: Leptospirosis
• Intervention / Treatment: Other: two additional blood samples specific to research

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Réunion
  • Saint-Benoît, Réunion, 97470
    • GHER
  • Saint-Denis, Réunion, 97400
    • CHU de la réunion
  • Saint-Paul, Réunion, 97460
    • CHOR
  • Saint-Pierre, Réunion, 97448
    • CHU de la réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient with leptospirosis	Other: two additional blood samples specific to research; proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes in the acute phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spirochaetales Infections; Leptospirosis; Weil Disease
• Other Study ID Numbers: 2017/CHU/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No