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临床试验/NCT02000635
NCT02000635Unknown不适用

Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique

University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014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
50
试验地点
1
主要终点
Change of concentration of leptospires in the blood during the first 7 days after the recruitment.

研究概览

简要总结

The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are described as meningitis, uveitis and classical severe presentation such as lung bleedings and liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the disease.

Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic confirmation during the first week of development and before the appearance of the first antibody.

If the microagglutination test (MAT) is considered the gold standard test for diagnosis of leptospirosis. However it requires rending samples to the referent National center for the leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the second week of illness. A second sample is required 15 days after the first one, to confirm the diagnosis.

In clinical practice , the technique of real-time PCR for the detection and quantification of pathogenic Leptospira during the first week of illness . The technique of diagnosis of leptospirosis by real-time PCR has been implemented and tested in 2007 at the University Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days, regardless of the severity of the disease. The evolution of leptospiremia treated patients has not been studied to date.

研究设计

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

入排标准

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

入选标准

  • Adults ( more than 18 years)
  • Diagnosis of leptospirosis confirmed by PCR in the five first day
  • Appeal to one of the hospital departments participating in the research: in emergency room, in complete hospitalization
  • Affiliated patients or beneficiaries of a national insurance scheme
  • Acceptance to participate in the study and in the proposed follow-up, and signature of the consent signed by the person or by his(her) representative

排除标准

  • Test of negative PCR
  • Children under age 18
  • No possible follow-up after the first visit
  • Pregnant patient
  • Refusal of participation in the study
  • Unaffiliated patients or beneficiaries of a national insurance scheme.

结局指标

主要结局

Change of concentration of leptospires in the blood during the first 7 days after the recruitment.

时间窗: At the recruitment, 24 hours, 48 hours 72 hours and the 7th day after the recruitment

For each patient, 5-6 quantitative PCR will be performed during the treatment at : The inclusion , 24 hours after the recruitment, 48 hours , 72 hours and the 7th day after the recruitment . In case of positive result of the quantitative PCR at the 7th day of treatment, late charge will be made around the 14th day.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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