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

C

Centre Hospitalier Universitaire de la Réunion

Status

Completed

Conditions

Leptospirosis

Treatments

Other: two additional blood samples specific to research

Study type

Interventional

Funder types

Other

Identifiers

NCT05413720
2017/CHU/14

Details and patient eligibility

About

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).

Enrollment

100 patients

Sex

All

Ages

4+ years old

Volunteers

No 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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Patient with leptospirosis
Other group
Treatment:
Other: two additional blood samples specific to research

Trial contacts and locations

4

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Central trial contact

Mélanie BEGORRE

Data sourced from clinicaltrials.gov

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