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Q Fever and Auto-immunity

Q Fever and Auto-immunity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02822807
Acronym
Q Fever
Enrollment
300
Registered
2016-07-04
Start date
2013-07-31
Completion date
2022-01-31
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auto-Immunity, Q Fever

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.

Interventions

BIOLOGICALBlood sampling

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 .

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of a complication, linked to the rate of autoantibodies.2 yearsThe 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

MeasureTime frame
Rate of anti- cardiolipin antibodies1 day
Rate of anti- phagosome autoantibodies1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026