Q Fever and Auto-immunity (Q Fever)

April 20, 2023 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille Cedex 05, France, 13385
        • Assistance Publique - Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of anti- cardiolipin antibodies
Time Frame: 1 day
1 day
Rate of anti- phagosome autoantibodies
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Didier RAOULT, PR, Assistance Publique - Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-31
  • 2013-A00963-42 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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