NCT06945822

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The goal of this study is to identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia. To achieve this goal, Individuals coming to the emergency department of the Centre Hospitalier Territorial de Nouvelle-Calédonie will be recruited either with suspected leptospirosis with signs and symptoms or healthy showing no infectious signs. For febrile patients with confirmed (group 1) or refuted (group 2) diagnosis of leptospirosis: * At D0: a 20-ml blood sample and a 5-ml urine sample * At D1, D3 and D15: a 20-ml blood sample For healthy patients (group 3): * At D0: a 20-ml blood sample and a 5-ml urine sample * At D15: a 20-ml blood sample. The analyses to be carried out are : * Host-pathogen sequencing, * Metagenomics, * Transcriptomics, * Metabolomics, * And cytokine assays to study the host immune response.

Conditions

• Leptospirosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-01
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2025-04-25
• Last updated: 2025-04-25