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Q Fever and Auto-immunity (Q Fever)

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ClinicalTrials.gov Identifier: NCT02822807
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Q Fever Auto-Immunity Biological: Blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Q Fever and Auto-immunity
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Q fever without valvular disease
Q fever without valvular disease
Biological: Blood sampling
Q fever with valvular disease
Q fever with valvular disease
Biological: Blood sampling
Q fever infective endocarditis
Q fever infective endocarditis
Biological: Blood sampling
Other Coxiella burnetii infections (including pregnant women)
Other Coxiella burnetii infections (including pregnant women)
Biological: Blood sampling



Primary Outcome Measures :
  1. Occurrence of a complication, linked to the rate of autoantibodies. [ Time Frame: 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 :
  1. Rate of anti- cardiolipin antibodies [ Time Frame: 1 day ]
  2. Rate of anti- phagosome autoantibodies [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822807


Contacts
Contact: Didier RAOULT, Pr 04 91 38 55 14 ext +33 didier.raoult@gmail.com
Contact: Alexandra Giuliani 04 91 38 28 70 ext +33 alexandra.giuliani@ap-hm.fr

Locations
France
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille Cedex 05, France, 13385
Contact: Didier RAOULT, Pr    04 91 38 55 14 ext +33    didier.raoult@gmail.com   
Contact: Alexandra GIULIANI    04 91 38 28 70    alexandra.giuliani@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Didier RAOULT, PR Assistance Publique - Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02822807     History of Changes
Other Study ID Numbers: 2013-31
2013-A00963-42 ( Other Identifier: ANSM )
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Fever
Q Fever
Autoimmune Diseases
Body Temperature Changes
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Immune System Diseases