Q Fever and Auto-immunity

Q Fever Clinical Trial

— Q Fever  

Official title:

Q Fever and Auto-immunity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822807
• Other study ID #: 2013-31
• Secondary ID: 2013-A00963-42
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: January 2022

Study information

• Verified date: October 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Auto-Immunity
• Autoimmune Diseases
• Fever
• Q Fever

Intervention

Biological:
• Blood sampling

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Marseille	Marseille Cedex 05

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a complication, linked to the rate of autoantibodies.	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 .	2 years
Secondary	Rate of anti- cardiolipin antibodies		1 day
Secondary	Rate of anti- phagosome autoantibodies		1 day