Status:
NOT_YET_RECRUITING
Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI
Lead Sponsor:
Institut Pasteur
Collaborating Sponsors:
Centre Terrritorial Hospitalier Gaston Bourret
Conditions:
Leptospirosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 est...
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 dep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06945822
Start Date
June 1 2025
End Date
July 1 2029
Last Update
April 25 2025
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