Q Fever and Auto-immunity (Q Fever)
Primary Purpose
Q Fever, Auto-Immunity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Q Fever
Eligibility Criteria
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 .
Sites / Locations
- Assistance Publique - Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Q fever without valvular disease
Q fever with valvular disease
Q fever infective endocarditis
Other Coxiella burnetii infections (including pregnant women)
Arm Description
Q fever without valvular disease
Q fever with valvular disease
Q fever infective endocarditis
Other Coxiella burnetii infections (including pregnant women)
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
Rate of anti- cardiolipin antibodies
Rate of anti- phagosome autoantibodies
Full Information
NCT ID
NCT02822807
First Posted
June 30, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02822807
Brief Title
Q Fever and Auto-immunity
Acronym
Q Fever
Official Title
Q Fever and Auto-immunity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
January 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Q Fever, Auto-Immunity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Q fever without valvular disease
Arm Type
Other
Arm Description
Q fever without valvular disease
Arm Title
Q fever with valvular disease
Arm Type
Other
Arm Description
Q fever with valvular disease
Arm Title
Q fever infective endocarditis
Arm Type
Other
Arm Description
Q fever infective endocarditis
Arm Title
Other Coxiella burnetii infections (including pregnant women)
Arm Type
Other
Arm Description
Other Coxiella burnetii infections (including pregnant women)
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Primary Outcome Measure Information:
Title
Occurrence of a complication, linked to the rate of autoantibodies.
Description
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 .
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rate of anti- cardiolipin antibodies
Time Frame
1 day
Title
Rate of anti- phagosome autoantibodies
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier RAOULT, PR
Organizational Affiliation
Assistance Publique - Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
12. IPD Sharing Statement
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Q Fever and Auto-immunity
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