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

Leptospirosis Clinical Trial

— IMMUNOLEPTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413720
• Other study ID #: 2017/CHU/14
• Status: Completed
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Leptospirosis

Intervention

Other:
• two additional blood samples specific to research
proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes in the acute phase

Locations

Country	Name	City	State
Réunion	GHER	Saint-Benoît
Réunion	CHU de la Réunion	Saint-Denis
Réunion	CHOR	Saint-Paul
Réunion	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes		at inclusion