Ex Vivo Study of Leukocyte Responses in the Blood of Patients With Leptospirosis and ex Vivo Testing of a New Host-targeted Therapeutic Strategy to Restore Phagocytosis of Leptospira (NEUTROLEPTO-NC)
Leptospirosis is a neglected zoonosis caused by pathogenic spirochetes of the genus *Leptospira*, occurring mainly in humid tropical and subtropical regions. With over one million cases and ~60,000 deaths annually, it is among the most dangerous bacterial zoonoses worldwide. Its nonspecific onset-fever, headache, myalgia-mimics influenza, dengue, and other acute febrile illnesses, making diagnosis difficult. Delayed antibiotic treatment can lead to severe forms (in ~10% of cases) characterized by hemorrhage and multi-organ failure. In 2023, New Caledonia reported 152 cases, with 85% hospitalized and a 2.6% mortality rate.
This study aims to characterize the human host response and improve patient management. *Leptospira* evades innate immunity, triggering a strong anti-inflammatory IL-10 response and potentially ineffective phagocytosis. However, the WHO-recommended β-lactam antibiotics induce a Jarisch-Herxheimer reaction (JHR)-an acute inflammatory response occurring within hours of treatment-in over 50% of patients (LEPJAR study, PMID:40986630), the impact of which on phagocytosis is unknown.The NEUTROLEPTO study will be conducted in New Caledonia (NC) in patients with or without leptospirosis. Clinical and biological data will be collected at the time of suspected infection and 3 hours after antibiotic administration. Specifically, immune responses will be assessed through cytokine profiling and blood cell phenotyping, as well as by transcriptome analysis of infected patients before and after antibiotic treatment.
연구 개요
상태
상세 설명
The aim of the study is to compare the immune cell responses in the blood of patients hospitalized for leptospirosis with those of patients with another infection, before and 3 hours after antibiotic therapy.
Individuals presenting to the emergency department of the Territorial Hospital Center of New Caledonia with signs and symptoms of leptospirosis will be recruited:
-with a confirmed diagnosis of leptospirosis (Group 1),-
-with an infectious diagnosis other than leptospirosis (Group 2)
Blood and clinical data will be collected from all the participants.
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Be of legal age (18 years or older at the time of enrollment),
- Be capable of understanding and providing informed consent,
- Have received information and provided written consent,
- Be enrolled in a social security program.
- Be suspected of having leptospirosis
Exclusion Criteria:
- With a chronic inflammatory disease,
- Whose health condition is incompatible with additional blood draws totaling 40 ml,
- Receiving concomitant treatment with antibiotics and/or anti-inflammatory drugs, or undergoing medical treatment incompatible with the study's objectives,
- Pregnant or breastfeeding women.
- Hospitalized or having undergone surgery within the previous 7 days
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Individuals with symptoms of leptospirosis with a confirmed diagnosis of leptospirosis
|
24 ml blood sample at H0
16 ml blood sample at H3
|
|
Individuals with symptoms of leptospirosis with a diagnosis of an infection other than leptospirosis
|
24 ml blood sample at H0
16 ml blood sample at H3
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
to compare the immune cell responses in the blood of patients hospitalized for leptospirosis with those of patients with another acute infection (MFA), both before and 3 hours after antibiotic treatment.
기간: 3 years
|
Flow cytometric phenotyping of different cell populations, as well as their activation markers and intracellular cytokines and measurement of cytokines using ELISA or LUMINEX in the blood (H0 at enrollment and H3, 3 hours after antibiotic administration) of individuals suspected of having leptospirosis
|
3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Test certain innovative host-based strategies aimed at restoring phagocytic responses against Leptospira in the blood of patients with leptospirosis.response.
기간: 3 years
|
Conduct ex vivo killing assays using patient blood in the presence of preparations based on so-called "natural" immunoglobulins to test a new host-targeted therapeutic strategy against leptospirosis.
|
3 years
|
|
Describe and characterise the Leptospira spp. strain
기간: 3 years
|
Measurement of bacterial load by PCR of the lipl32 gene, identification of the Leptospira spp.
genogroup by bacterial DNA sequencing or other molecular biology methods (PCR) and/or of the serovar by MAT, sequencing of the bacterial mRNA.
|
3 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-146 (Ethics Committee of Shanghai Sixth People's Hospital)
- 2025-A02688-41 (기타 식별자: ID-RCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .