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NCT Number: NCT07305402

Vascular Infections Caused by Coxiella Burnetii

high morbidity and mortality. In France, Coxiella burnetii-related vascular infections appear to be increasing, though data remain limited. Two-year mortality reaches 15-18%, mainly due to serious complications such as arterio-digestive fistulas. Diagnosis is often delayed, prognostic factors are poorly defined, and the value of advanced imaging techniques remains insufficiently studied.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Q fever is a worldwide zoonosis that may cause chronic vascular infections with significant morbidity and mortality. In France, the incidence of Coxiella burnetii-related vascular infections appears to be increasing, although published data remain scarce. Reported two-year mortality reaches 15-18%, largely due to severe complications such as arterio-digestive fistulas. Classical risk factors include aortic aneurysm and vascular grafts, but many patients present without clear zoonotic exposure, leading to frequent underdiagnosis. Prognostic factors are poorly defined, apart from the lack of surgical management, which worsens outcomes. Diagnosis is often delayed, and the value of advanced imaging modalities such as 18F-FDG PET/CT or labeled leukocyte scintigraphy remains insufficiently studied.

Who can participate

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

Inclusion criteria

  • Adults (≥ 18yrs old) with native or prosthetic vascular infection due to C. burnetii (Jan 2000 - Dec 2023)
  • diagnosis based on CNR vascular Q fever criteria,
  • supplemented by MAGIC (Management of Aortic Graft Infection Collaboration) criteria for prosthetic/ - endovascular infections or aortitis/arteritis criteria,
  • no objection to reuse of patient data.

Exclusion criteria

  • patient under legal protection,
  • insufficient French language comprehension

Treatment and study plan

Primary outcomes

  1. two-year mortality rate

    Time frame: 2 years

    from the time of initial management

Secondary outcomes

  1. Early mortality rate

    Time frame: Day 30

    Early mortality rate (Day 30)

  2. Infection-attributed mortality rate

    Time frame: 2 years

    Infection-attributed mortality rate

  3. Two-year morbidity rate

    Time frame: 2 years

    Two-year morbidity rate

  4. Rate of initial complications

    Time frame: 2 years

    Rate of initial complications

  5. Rate of postoperative complications

    Time frame: 2 years

    Rate of postoperative complications

  6. Diagnostic performance of the different imaging modalities

    Time frame: 2 years

    Diagnostic performance of the different imaging modalities

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde Puges, MD

CONTACT

[email protected]

+335 56 79 55 36

Zoe Blanc, MD

CONTACT

[email protected]

+335 56 79 55 36

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

A French Multicenter Retrospective Study of Native and Prosthetic Vascular Infections Caused by Coxiella Burnetii (COXIVAS)

Acronym: COXIVAS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

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.