Clinical Trial: Q Fever and Auto-immunity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Q Fever and Auto-immunity

Brief Summary: 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.

Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

Current Primary Outcome: Occurrence of a complication, linked to the rate of autoantibodies. [ Time Frame: 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 .


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of anti- cardiolipin antibodies [ Time Frame: 1 day ]
  • Rate of anti- phagosome autoantibodies [ Time Frame: 1 day ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: June 30, 2016
Date Started: July 2013
Date Completion: January 2019
Last Updated: June 30, 2016
Last Verified: June 2016