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OpenTrials
Completed

NCT Number: NCT02822807

Q Fever and Auto-immunity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Marseille

Marseille, 13385, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Blood sampling

Biological

Primary outcomes

  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 outcomes

  1. Rate of anti- cardiolipin antibodies

    Time frame: 1 day

  2. Rate of anti- phagosome autoantibodies

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: Q Fever

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Jul 4, 2016
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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