Q Fever and Auto-immunity

Not Applicable

Completed

• Conditions: Q Fever; Auto-Immunity
• Interventions: Biological: Blood sampling

• Registration Number: NCT02822807
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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 Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-04
• Primary Completion: 2021-07
• Study Completion: 2022-01
• Status Verified: 2022-10
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Q fever infective endocarditis	Blood sampling	Q fever infective endocarditis
Q fever without valvular disease	Blood sampling	Q fever without valvular disease
Q fever with valvular disease	Blood sampling	Q fever with valvular disease
Other Coxiella burnetii infections (including pregnant women)	Blood sampling	Other Coxiella burnetii infections (including pregnant women)

Primary Outcome Measures

Name	Time	Method
Occurrence of a complication, linked to the rate of autoantibodies.	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 Outcome Measures

Name	Time	Method
Rate of anti- cardiolipin antibodies	1 day
Rate of anti- phagosome autoantibodies	1 day

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Marseille; 🇫🇷 Marseille Cedex 05, France