Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI
NCT06945822 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2025-04-25
Summary
Leptospirosis is a zoonosis found worldwide, but particularly in humid subtropical and tropical zones. It is caused by pathogenic bacteria of the Leptospira species of the spirochete family. It is estimated that there are over a million cases of leptospirosis worldwide each year, with 60,000 deaths. These figures place leptospirosis among the most dangerous bacterial zoonoses in the world.
The disease affects the most disadvantaged populations, and also inflicts its burden on domestic and farm animals. To this day, however, leptospirosis remains a neglected disease, poorly understood because it has been little studied.
Human leptospirosis initially presents as a febrile syndrome, with fever, headache, myalgia and joint pain. These symptoms are very similar to those observed in influenza, dengue fever and other acute febrile illnesses, making diagnosis very difficult.
Delayed initiation of antibiotic therapy, a treatment recommended by the WHO, is associated with the development of severe forms of leptospirosis. Indeed, in 10% of cases, leptospirosis evolves into severe forms, which are still poorly described, but which result in haemorrhage, multivisceral failure (lungs, kidneys, liver) and a drastic increase in the case-fatality rate. In 2023, 152 cases of leptospirosis were reported in New Caledonia. Of these, 130 people (85%) were hospitalized and 4 deaths were recorded (2.6%).
For patients suffering from leptospirosis, it is therefore important to be able to make the diagnosis quickly, ideally as soon as symptoms appear. It is also crucial to be able to monitor, or even prevent, the development of severe forms of the disease, to ensure optimal patient care.
Conditions
- Leptospirosis
Interventions
- OTHER
-
Blood sample
For febrile patients with confirmed (group 1) or refuted (group 2) diagnosis of leptospirosis: \- At D0, D1, D3 and D15 a 20-ml blood sample For healthy patients (group 3): \- At D0 and D15: a 20-ml blood sample
- OTHER
-
Urine Sample
For all participants, a 5-ml urine sample at D0
Sponsors & Collaborators
-
Centre Terrritorial Hospitalier Gaston Bourret
collaborator UNKNOWN -
Institut Pasteur
lead INDUSTRY
Principal Investigators
-
Frédéric Veyrier, PhD · Institut Pasteur de Nouvelle-Calédonie
-
Cécile Cazorla, MD · Centre Hospitalier Territorial Gaston-Bourret
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2029-07-01
- Completion
- 2029-07-01
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