Vascular Infection Caused by C. BurnetiiCOXIVASNCT07305402
Vascular Infections Caused by Coxiella Burnetii
An observational study of Vascular Infection Caused by C. Burnetii, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Infection Caused by C. Burnetii
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults (≥ 18yrs old) with native or prosthetic vascular infection due to C. burnetii
Who may be able to join
- 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.
Who cannot join
- patient under legal protection,
- insufficient French language comprehension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Bordeaux
Bordeaux
Mathilde Puges, MD, +335 56 79 55 36, mathilde.puges@chu-boreaux.fr
Zoe Blanc, MD, zoe.blanc@chu-bordeaux.fr
About this study
Official title: A French Multicenter Retrospective Study of Native and Prosthetic Vascular Infections Caused by Coxiella Burnetii (COXIVAS)
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.
Read the detailed description
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.
- Conditions
- Vascular Infection Caused by C. Burnetii
- Keywords
- vascular infection, vascular graft infection, vascular endograft infection, Coxiella burnetii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic vascular infection due to C. burnetii | Adults with native or prosthetic vascular infection due to C. burnetii |
What is being measured
The primary outcome is the main question the study is designed to answer.
two-year mortality rate
from the time of initial management
Measured: 2 years
Secondary outcomes (6)
Early mortality rate
Early mortality rate (Day 30)
Measured: Day 30
Infection-attributed mortality rate
Infection-attributed mortality rate
Measured: 2 years
Two-year morbidity rate
Two-year morbidity rate
Measured: 2 years
Rate of initial complications
Rate of initial complications
Measured: 2 years
Rate of postoperative complications
Rate of postoperative complications
Measured: 2 years
Diagnostic performance of the different imaging modalities
Diagnostic performance of the different imaging modalities
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Infection Caused by C. BurnetiiStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305402
- Sponsor's protocol ID
- CHUBX 2025/024
- Acronym
- COXIVAS
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Multicenter Retrospective Study of Native and Prosthetic Vascular Infections Caused by Coxiella Burnetii (COXIVAS)
- ClinicalTrials.gov ID
- NCT07305402
- Acronym / sponsor ID
- COXIVAS / CHUBX 2025/024
- Conditions
- Vascular Infection Caused by C. Burnetii
- Keywords
- vascular infection, vascular graft infection, vascular endograft infection, Coxiella burnetii
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic vascular infection due to C. burnetii | – | –Adults with native or prosthetic vascular infection due to C. burnetii |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults (≥ 18yrs old) with native or prosthetic vascular infection due to C. burnetii
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- patient under legal protection,
- insufficient French language comprehension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
two-year mortality rate
Time frame: 2 years
from the time of initial management
6 secondary outcomes
Early mortality rate
Time frame: Day 30
Infection-attributed mortality rate
Time frame: 2 years
Two-year morbidity rate
Time frame: 2 years
Rate of initial complications
Time frame: 2 years
Rate of postoperative complications
Time frame: 2 years
Diagnostic performance of the different imaging modalities
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Infection Caused by C. Burnetii, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Puges, MD (+335 56 79 55 36, mathilde.puges@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
two-year mortality rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.