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

ConditionLeptospirosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Pasteur

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be able to consent,

Have received information and given written consent,

Be covered by a social security plan. For groups 1 & 2: febrile individuals

Other acute bacterial zoonotic infection: Infection confirmed by paired serology or double PCR (2 targets).

Disqualifiers

with a chronic inflammatory disease,

undergoing concomitant antibiotic and/or anti-inflammatory treatment, or under medical care incompatible with the purpose of the study,

pregnant or breast-feeding women,

persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social institution,

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample

    Other intervention

    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

  • Urine Sample

    Other intervention

    For all participants, a 5-ml urine sample at D0

Treatment groups

450 Participants
are divided into 1 treatment group
Group A: Individuals coming to the emergency department of the CHTOther 2 interventions

Trial outcomes

Primary outcomes

1

Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia.

transcriptome study by sequencing host mRNA at different times, in the blood and urine of individuals suspected of having leptospirosis

Time frame
4 years
2

Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia.

level of cytokines present at different times, in the blood and urine of individuals suspected of having leptospirosis

Time frame
4 years
3

Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia.

identification of the Leptospira spp. serogroup by sequencing bacterial DNA or PCR at different times, in the blood and urine of individuals suspected of having leptospirosis

Time frame
4 years

Secondary outcomes

1

Develop and validate biomarkers that have already been identified for accurate diagnosis of leptospirosis of varying clinical severity.

Transcriptome study using host mRNA sequencing

Time frame
4 years
2

Develop and validate biomarkers that have already been identified for accurate diagnosis of leptospirosis of varying clinical severity.

Level of cytokines or other markers previously identified as biomarkers of severity.

Time frame
4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Pasteur

Lead sponsor

Centre Terrritorial Hospitalier Gaston Bourret

Collaborator

This trial is not recruiting at the moment. You can still explore other options: