Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 5
- 主要终点
- Incidence of JHR during follow-up of patients with leptospirosis at the initiation of antibiotic therapy.
研究概览
简要总结
The objective of the study is to estimate the incidence of Jarisch-Herxheimer Reactions (JHR) during antibiotic treatment of human leptospirosis cases in New Caledonia.
Participants are patients managed in one of the 5 centres participating in the study, in whom a clinical doctor suspected leptospirosis. The average number of leptospirosis cases in New Caledonia is 89 per year. Given the proportion of positive diagnostic tests (approximately 10%) 900 inclusions are planned for this study.
Patients are included at the time of the consultation during which leptospirosis is suspected, before the initiation of their antibiotic therapy and independently of the clinical form they presented.
Data (socio-demographic and health) and blood samples will be collected at 3 points in the study: at baseline, three hours and six hours after antibiotic treatment.
This study will allow better management of patients with leptospirosis.
详细描述
The objective of the study is to estimate the incidence of Jarisch-Herxheimer Reactions (JHR) during antibiotic treatment of human leptospirosis cases in New Caledonia.
Secondary objectives of the study are to describe the JHR during leptospirosis (describe clinical, haemodynamic and cytokine response parameters), to describe the effects of the progressive introduction of antibiotic (ATB) for the treatment of leptospirosis and to harmonise management practices for patients with leptospirosis in NC.
Participants are patients managed in one of the 5 centres participating in the study, in whom a clinical doctor suspected leptospirosis. The average number of leptospirosis cases in New Caledonia (NC) is 89 per year. Given the proportion of positive diagnostic tests (approximately 10%) 900 inclusions are planned for this study.
Patients are included at the time of the consultation during which leptospirosis is suspected, before the initiation of their antibiotic therapy and independently of the clinical form they presented.
Blood samples will be collected at 3 points in the study: at baseline, three hours and six hours after antibiotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be over 18 years of age (at the time of inclusion);
- •Be suspected of developing leptospirosis by the clinician in one of the 5 participating centres
- •Have been informed of the use of their samples for non-therapeutic scientific research purposes by a note and information sheet established by the Institut Pasteur of New Caledonia (IPNC) and the Institut Pasteur Paris (IPP), provided and explained by the inclusion centre.
- •Have expressed their oral consent to participate in this research project
- •Non inclusion criteria:
- •Under 18 years of age
- •Have not given oral consent to participate
- •Have a chronic inflammatory disease.
- •Having concomitant antibiotic and/or anti-inflammatory treatment or medical management incompatible with the purpose of the study,
- •Pregnant or breastfeeding women.
排除标准
- •Leptospirosis diagnostic is not confirmed by molecular biology. Complete destruction of the corresponding samples will be ensured. Clinical data and biological analyses will also be removed from the data associated with the research.
结局指标
主要结局
Incidence of JHR during follow-up of patients with leptospirosis at the initiation of antibiotic therapy.
时间窗: 1 year
The incidence of JHR will be calculated on the total number of patients included by recording the number of participants who developed or showed an aggravation of at least one of the following clinical symptoms: Fever, tremor, chills, headache, muscle stiffness and/or pain and change in the patient's haemodynamic status (blood pressure, pulse, respiratory rate, oxygen saturation).
次要结局
- Description of the administration of antibiotic treatment used for leptospirosis.(1 year)
- Association of markers of inflammation with the onset of JHR.(1 year)
- Description of JHR during leptospirosis(1 year)
- Description of inflammatory markers during JHR(1 year)