NCT02822807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 21, 2023

Status Verified

October 1, 2022

Enrollment Period

8 years

First QC Date

June 30, 2016

Last Update Submit

April 20, 2023

Conditions

Q FeverAuto-Immunity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rate of anti- cardiolipin antibodies

    1 day

  • Rate of anti- phagosome autoantibodies

    1 day

Study Arms (4)

Q fever without valvular disease

OTHER

Q fever without valvular disease

Biological: Blood sampling

Q fever with valvular disease

OTHER

Q fever with valvular disease

Biological: Blood sampling

Q fever infective endocarditis

OTHER

Q fever infective endocarditis

Biological: Blood sampling

Other Coxiella burnetii infections (including pregnant women)

OTHER

Other Coxiella burnetii infections (including pregnant women)

Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL
Other Coxiella burnetii infections (including pregnant women)Q fever infective endocarditisQ fever with valvular diseaseQ fever without valvular disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Minor patient (\<18 years )
  • Adult patient under guardianship .
  • Patient deprived of liberty or judgment.
  • Patient refusing to sign the informed consent form .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, 13385, France

Location

MeSH Terms

Conditions

Q Fever

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Didier RAOULT, PR

    Assistance Publique - Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

July 1, 2013

Primary Completion

July 1, 2021

Study Completion

January 1, 2022

Last Updated

April 21, 2023

Record last verified: 2022-10

Locations

FR(1)