Q Fever and Auto-immunity

NCT ID: NCT02822807

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2022-01-31

Brief Summary

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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

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Conditions

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Q Fever Auto-Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Q fever without valvular disease

Q fever without valvular disease

Group Type OTHER

Blood sampling

Intervention Type BIOLOGICAL

Q fever with valvular disease

Q fever with valvular disease

Group Type OTHER

Blood sampling

Intervention Type BIOLOGICAL

Q fever infective endocarditis

Q fever infective endocarditis

Group Type OTHER

Blood sampling

Intervention Type BIOLOGICAL

Other Coxiella burnetii infections (including pregnant women)

Other Coxiella burnetii infections (including pregnant women)

Group Type OTHER

Blood sampling

Intervention Type BIOLOGICAL

Interventions

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Blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier RAOULT, PR

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Marseille

Locations

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Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00963-42

Identifier Type: OTHER

Identifier Source: secondary_id

2013-31

Identifier Type: -

Identifier Source: org_study_id

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