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NOT YET RECRUITING
NCT06945822
NA

Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI

Sponsor: Institut Pasteur

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-06-01

Completion Date

2029-07-01

Last Updated

2025-04-25

Healthy Volunteers

Yes

Conditions

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