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临床试验/NCT02822807
NCT02822807已完成不适用

Q Fever and Auto-immunity

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Occurrence of a complication, linked to the rate of autoantibodies.

研究概览

简要总结

The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • Patients with a current or former Q fever diagnosis
  • Patient > 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

  • Minor patient (<18 years )
  • Adult patient under guardianship .
  • Patient deprived of liberty or judgment.
  • Patient refusing to sign the informed consent form .

结局指标

主要结局

Occurrence of a complication, linked to the rate of autoantibodies.

时间窗: 2 years

The required complications are the followings: * endocarditis * thrombosis * thrombocytopenia * obstetrical complications: * Spontaneous miscarriage defined as a spontaneous expulsion of the embryo before 20 weeks gestation . * Spontaneous abortion * Fetal intrauterine death * Oligoamnios * Intrauterine growth retardation * Fetal malformations .

次要结局

  • Rate of anti- cardiolipin antibodies(1 day)
  • Rate of anti- phagosome autoantibodies(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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