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

NCT06945822 | Not Yet Recruiting

• 2 other identifiers: 2024-0772024-A02827-40
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Leptospirosis

Keywords

biomarkers; New Caledonia; infection

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  4 years

Secondary Outcomes (2)

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

  4 years

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

  4 years

Study Arms (1)

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.

Other: Blood sample; Other: Urine Sample

Interventions

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

Individuals coming to the emergency department of the CHT

Urine Sample OTHER

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

Individuals coming to the emergency department of the CHT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur: lead
• Centre Terrritorial Hospitalier Gaston Bourret: collaborator

MeSH Terms

Conditions

Leptospirosis; Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Frédéric Veyrier, PhD

  Institut Pasteur de Nouvelle-Calédonie

  STUDY DIRECTOR

• Cécile Cazorla, MD

  Centre Hospitalier Territorial Gaston-Bourret

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Loarec, MD

CONTACT

+687 90 86 21; anloarec@pasteur.nc

Frédéric Veyrier, PhD

CONTACT

+687 273634; fveyrier@pasteur.nc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 25, 2025

Record last verified: 2025-04