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临床试验/NCT02868450
NCT02868450已完成不适用

Chronic Infection With Tropheryma Whipplei: Risk Factors Related to the Host

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2013年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
246
试验地点
2
主要终点
Proportion of patients with HLA-DRB 13 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients

研究概览

简要总结

In 2012, a previous work showed that T. whipplei is a common bacterium detected in various situations. A large part of the population is therefore exposed to a T. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. The association teams with experience in HLA-typing will allow us to better identify patients with a risk of chronic complication.

The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple disease and/ or, endocarditis and/or encephalitis).

详细描述

Since the first isolation of a strain of Tropheryma whipplei (T. whipplei) and the development of molecular tools, the natural history of this bacterium continued to clarify. The currently proposed scheme is as follows: after contamination human oral-oral or fecal, patients will develop acute infections such as bacteremia, gastroenteritis and pneumonia. They can then produce specific antibodies. Likely depending on the host-related factors, three types of evolution appear to be possible: (i) some patients eliminate the bacteria and develop specific antibodies. (ii) some patients are chronic carriers of the bacterium with a strong immune response. (iii) Finally, patients develop subacute or chronic infections, with an insufficient immune response or non-existent answer to T. whipplei.

Subacute or chronic infections include Whipple's disease characterized by histological involvement of the small intestine, as well as localized without digestive impairment, such as endocarditis or encephalitis. Despite appropriate antibiotic therapy, patients with Whipple's disease will present relapse (30-40% of patients), but also of re-infection with different genotypes of T. whipplei.

Here the hypothesis is that HLA-DRB 13 and/or HLA-DQB1 06 alleles are associated with the presence of chronic infections with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patient with a positive PCR to T. Whipplei diagnostics.
  • Patient aged > or = 18 years old.
  • Patient who does not declined to have his medical records reviewed for research.
  • Patient with health insurance.

排除标准

  • Patient minors (age <18 years)
  • Pregnant woman, parturient or breastfeeding
  • Adult Patient under guardianship .
  • Patient deprived of liberty under court order
  • Patient refusing to sign the informed consent form.

结局指标

主要结局

Proportion of patients with HLA-DRB 13 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients

时间窗: 1 day

Proportion of patients with HLA-DQB1 06 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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