Q Fever and Auto-immunity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Occurrence of a complication, linked to the rate of autoantibodies.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Minor patient (<18 years )
- •Adult patient under guardianship .
- •Patient deprived of liberty or judgment.
- •Patient refusing to sign the informed consent form .
Outcomes
Primary Outcomes
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 .
Secondary Outcomes
- Rate of anti- cardiolipin antibodies(1 day)
- Rate of anti- phagosome autoantibodies(1 day)