Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
IMMUNOLEPTO
1 other identifier
interventional
100
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2021
CompletedFirst Submitted
Initial submission to the registry
June 3, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2022
CompletedOctober 25, 2023
August 1, 2023
1.5 years
June 3, 2022
October 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes
at inclusion
Study Arms (1)
Patient with leptospirosis
OTHERInterventions
proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes in the acute phase
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
GHER
Saint-Benoît, 97470, Reunion
CHU de la Réunion
Saint-Denis, 97400, Reunion
CHOR
Saint-Paul, 97460, Reunion
CHU de la Réunion
Saint-Pierre, 97448, Reunion
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2022
First Posted
June 10, 2022
Study Start
January 6, 2021
Primary Completion
July 20, 2022
Study Completion
July 20, 2022
Last Updated
October 25, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share