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Completed

NCT Number: NCT05413720

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

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Key information

Conditions

Leptospirosis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Spirochaetales Infections

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHER, Saint-Benoît, Reunion

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

two additional blood samples specific to research

Other

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

Primary outcomes

  1. proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes

    Time frame: at inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: IMMUNOLEPTO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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