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临床试验/NCT01607047
NCT01607047Unknown不适用

Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies

University Hospital Center of Martinique2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Complicated forms of leptospirosis

研究概览

简要总结

Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the tropics, where conditions for transmissions are favorable. The disease is endemic in Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains and contaminate the environment by shedding the organisms in their urine. Humans are usually infected through abraded skin or mucous membrane contact with water contaminated by the urine of animal reservoirs, and less frequently by direct contact with animals or their urine. The mean incubation period is 10 days, with a usual range of 2-20 days. Clinical manifestations are protean and the spectrum of symptoms range from subclinical or mild anicteric febrile illness to acute renal failure and respiratory distress syndrome which are associated with high mortality rates.

The microscopic agglutination test (MAT) and culture are the reference standard test for diagnosis of leptospirosis, but they are only available in reference laboratories and their conclusive results requires convalescent sample or prolonged incubation. At present, only direct detection methods using PCR might provide rapid diagnosis during the early acute stage of the illness, when treatment is likely to have the greatest benefit.

Quantitative PCR also offers the ability to measure level of leptospiremia in clinical samples. Using qPCR based diagnosis, the investigators have the opportunity to study the association of level of leptospiremia and clinical manifestations in French West Indies. All qPCR-positive samples will be used for molecular typing.

详细描述

Principal objective

To determine if leptospiral bacterial load is associated with severe evolution of the disease (organ failure, internal bleeding, death) in French West Indies.

Secondary objective

  1. To identify demographic, clinical, biological, bacteriological, and genetic factors (HLA) associated with severe complications of leptospirosis (organ failure, internal bleeding, death).
  2. To identify demographic, clinical, biological, bacteriological, and genetic factors (HLA) associated with an altered quality of life after the acute phase of leptospirosis.
  3. To collect human biological samples to allow studies of the individual susceptibility to the infection (genetic polymorphisms, HLA).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (more than 18 years)
  • Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit).
  • Diagnosis of leptospirosis confirmed by qPCR
  • Possibility of follow-up throughout the 12-week study period.
  • Patient registered in the French medical social security national program
  • Acceptance to participate in the study and in follow-up; informed consent of the patient or a legal representative (patients unable to sign the consent form).

排除标准

  • Negativity of leptospirosis qPCR based diagnosis
  • Children under 18 years old
  • No possible follow-up after the first visit
  • Refusal to participate in the study
  • Patient not registered in the French medical social security national program

结局指标

主要结局

Complicated forms of leptospirosis

时间窗: 12 weeks

Occurrence, during follow-up (for 12 weeks following symptom onset), of shock, internal bleeding, failure of one or several organs or systems (brain, heart, lung, liver, kidney, clotting system), or death.

次要结局

  • quality of life(12 weeks)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (2)

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