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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05413720

Acronym

IMMUNOLEPTO

Enrollment

100

Registered

2022-06-10

Start date

2021-01-06

Completion date

2022-07-20

Last updated

2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptospirosis

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).

Interventions

OTHERtwo additional blood samples specific to research

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Reunion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026