Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06945822

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Leptospirosis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Spirochaetales Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.

Exclusion criteria

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
  • 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.

Treatment and study plan

blood sample

Other

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

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

    Time frame: 4 years

    Transcriptome study using host mRNA sequencing

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

    Time frame: 4 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Loarec, MD

CONTACT

[email protected]

+687 90 86 21

Frédéric Veyrier, PhD

CONTACT

[email protected]

+687 273634

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Centre Terrritorial Hospitalier Gaston Bourret

Registry information

Acronym: NIHFI

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.