LeptospirosisNIHFINCT06945822
Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI
A study testing Blood sample and Urine Sample in people with Leptospirosis, run by Institut Pasteur.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leptospirosis
- What is being tested?
- Blood sample and Urine Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants :
- Be able to consent,
- Have received information and given written consent,
- Be covered by a social security plan. For groups 1 \& 2: febrile individuals
- Have suspected leptospirosis associated with fever (axillary temperature over 38°C) and a clinical picture of suspected leptospirosis (myalgia, headache...). After inclusion, febrile participants will be divided into 2 groups when the diagnosis of leptospirosis is confirmed. The 2 groups are defined as follows:
- Group 1: leptospirosis
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- Individual with leptospirosis confirmed by PCR, MAT, or isolation (2013 Center For Disease Control and Prevention (CDC) laboratory criteria for a confirmed diagnosis).
- Group 2: MFA, with absence of leptospirosis
- All individuals in Group 2 will have tests as part of their MFA diagnosis, depending on their symptomatology:
- Other acute bacterial zoonotic infection: Infection confirmed by paired serology or double PCR (2 targets).
- Acute arboviral infection: dengue, chikungunya or Zika virus confirmed by CDC Trioplex PCR in a patient with consistent serology or positive 2nd target PCR.
- Acute respiratory viral infection: Viral agent confirmed by MFA multiplex PCR. For group 3: healthy individuals
- Apyretic individuals, no symptoms of infection or inflammatory disease in the last 28 days.
Who cannot join
- individuals :
- 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,
- Adults subject to a legal protection measure or unable to express their consent
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- Persons not affiliated to a social security scheme or beneficiaries of such a scheme
- Hospitalized for more than 48 hours,
- Hospitalized or operated on in the previous 7 days.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Blood sample, Urine Sample
- Keywords
- biomarkers, New Caledonia, infection
- Medical subject headings
- Leptospirosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
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 SampleOther
For all participants, a 5-ml urine sample at D0
| Study group | Role | What they receive |
|---|---|---|
| Individuals coming to the emergency department of the CHT | Other | Individuals coming to the emergency department of the Centre Hospitalier Territorial de New Caledonia:
* Either with suspected leptospirosis with signs and symptoms
* Or healthy and coming for a traumatology and orthopedics consultation, and showing no infectious signs. Receives: Other: Blood sample; Other: Urine Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
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
Measured: 4 years
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
Measured: 4 years
Secondary outcomes (2)
Develop and validate biomarkers that have already been identified for accurate diagnosis of leptospirosis of varying clinical severity.
Transcriptome study using host mRNA sequencing
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Terrritorial Hospitalier Gaston Bourret
- Responsible party
- Sponsor
- Investigators
- Frédéric Veyrier, PhD, Study director, Institut Pasteur de Nouvelle-CalédonieCécile Cazorla, MD, Principal investigator, Centre Hospitalier Territorial Gaston- Bourret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945822
- Sponsor's protocol ID
- 2024-077
- Other IDs
- 2024-A02827-40
- Acronym
- NIHFI
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI
- ClinicalTrials.gov ID
- NCT06945822
- Acronym / sponsor ID
- NIHFI / 2024-077
- Conditions
- Leptospirosis
- Keywords
- biomarkers, New Caledonia, infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Centre Terrritorial Hospitalier Gaston Bourret
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals coming to the emergency department of the CHT | Other | Other: Blood sample, Other: Urine SampleIndividuals coming to the emergency department of the Centre Hospitalier Territorial de New Caledonia: * Either with suspected leptospirosis with signs and symptoms * Or healthy and coming for a traumatology and orthopedics consultation, and showing no infectious signs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be able to consent,
- Have received information and given written consent,
- Be covered by a social security plan. For groups 1 \& 2: febrile individuals
- Have suspected leptospirosis associated with fever (axillary temperature over 38°C) and a clinical picture of suspected leptospirosis (myalgia, headache...). After inclusion, febrile participants will be divided into 2 groups when the diagnosis of leptospirosis is confirmed. The 2 groups are defined as follows:
- Group 1: leptospirosis
Key exclusion criteria (9 listed)
- 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,
- Adults subject to a legal protection measure or unable to express their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleFor 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 | Individuals coming to the emergency department of the CHT |
| Urine SampleFor all participants, a 5-ml urine sample at D0 | Other | Individuals coming to the emergency department of the CHT |
Primary outcome
Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia.
Time frame: 4 years
transcriptome study by sequencing host mRNA at different times, in the blood and urine of individuals suspected of having leptospirosis
Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia.
Time frame: 4 years
level of cytokines present at different times, in the blood and urine of individuals suspected of having leptospirosis
Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia.
Time frame: 4 years
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
2 secondary outcomes
Develop and validate biomarkers that have already been identified for accurate diagnosis of leptospirosis of varying clinical severity.
Time frame: 4 years
Develop and validate biomarkers that have already been identified for accurate diagnosis of leptospirosis of varying clinical severity.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric Veyrier, PhD study director
Institut Pasteur de Nouvelle-Calédonie
Cécile Cazorla, MD principal investigator
Centre Hospitalier Territorial Gaston- Bourret
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Urine Sample in people with Leptospirosis, run by Institut Pasteur.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Loarec, MD (+687 90 86 21, anloarec@pasteur.nc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify diagnostic and prognostic biomarkers based on host response to human leptospirosis in New Caledonia. (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.