Aortic Infections and InflammationsRepiaNCT05660733
Study of the Aortic and Large Arterial Vessel Infections
An observational study of Aortic Infections and Inflammations and Mycotic Aneurysm, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Aortic or large arterial vessel infections are rare but serious infections. Their management is based on French and American expert opinions. The quality of evidence supporting these guidelines is low because most publications on the subject correspond to case series and few interventional studies have been performed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Infections and Inflammations, Mycotic Aneurysm, Arterial Infections and Inflammations
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2023to 1 Jan 2027
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adults patients with proved aortic or large arterial vessel infection and without exclusion criteria.
Who may be able to join
- Age ≥ 18 years
- Aortic or large arterial vessel infection. The diagnosis is made on a number of criteria in favour of the diagnosis (at least 2 of the following 3 criteria):
- Compatible clinical presentation: local or general inflammatory signs suggestive of a deep infection (fever, chills, scar discharge, fistula, febrile abdominal pain and low back pain, ...) or per-operative finding of an infection in contact with native or prosthetic vascular tissue
- And/or biological (inflammatory syndrome) and/or imaging evidence (infectious sign on native, bioprosthetic or prosthetic vascular tissue on CT and/or PET scan) in favour of the diagnosis
- And/or microbiological evidence (positive serologies, blood cultures or deep samples in favour of infection)
Who cannot join
- Patient who objected to participation in this protocol and data collection
- Pregnant woman, parturient or breastfeeding mother
- Person deprived of liberty by a judicial or administrative decision,
- Person subject to psychiatric care by virtue of articles L.3212-1 and L.3213-1 of the French public health code
- Person subject to a legal protection measure
- Person unable to give consent
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, 1 recruiting
- Recruiting
Université de Lorraine, CHRU Nancy and APEMAC
Vandœuvre-lès-Nancy, Lorraine, 54511
Lefevre Benjamin, M.D., +33383157654, b.lefevre@chru-nancy.fr
About this study
Official title: French Registry Studying the Characteristics and Prognosis of Aortic and Large Arterial Vessel Infections
Aortic or large arterial vessel infections are rare but serious infections. Their management is based on French and American expert opinions. The quality of evidence supporting these guidelines is low because most publications on the subject correspond to case series and few interventional studies have been performed to validate their management. However, referral centres for vascular surgery are frequently solicited to give their opinion on patients suffering from mycotic aneurysms. In addition, the last few decades have seen the improvement of vascular surgery techniques allowing the management of more and more patients, often elderly and comorbid. There has therefore been an increase in the incidence of infectious complications associated with this care. It is therefore essential to participate in research on aortic and large arterial vessel infections. For this, a monocentric cohort study seems to be an essential first step to better understand the polymorphism and complexity of these patients.
- Conditions
- Aortic Infections and Inflammations, Mycotic Aneurysm, Arterial Infections and Inflammations, Prosthetic Infection
- Medical subject headings
- Inflammation, Aneurysm, Infected
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year mortality
Study of all-cause mortality in patients with aortic vascular infection and large arterial vessels during the first year of follow-up after diagnosis.
Measured: one year after the diagnosis
Secondary outcomes (1)
Identification of prognostic factors associated with arterial vascular infections
Identification of prognostic factors in patients with aortic and large arterial vessel infection: a multivariate Cox model to identify factors associated with mortality or better survival
Measured: at the time of diagnosis and up to one year afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start30 Jun 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Infections and InflammationsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEFEVRE Benjamin, Central Hospital, Nancy, France
- Investigators
- Lefèvre Benjamin, M.D., Principal investigator, Université de Lorraine & CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660733
- Sponsor's protocol ID
- Research on existing data
- Acronym
- Repia
- Status last verified
- Aug 2025
- First submitted
- 7 Dec 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lalevee L, Serguei M, Jeanbert E, Simon M, Luc A, Settembre N, Henard S, Novy E, Guerci P, Lefevre B. Characteristics and outcomes of patients with infective native aortic aneurysm or vascular graft and endograft infection. Infect Dis (Lond). 2025 Oct;57(10):920-932. doi: 10.1080/23744235.2025.2502826. Epub 2025 May 16.
PubMed 40377031
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Registry Studying the Characteristics and Prognosis of Aortic and Large Arterial Vessel Infections
- ClinicalTrials.gov ID
- NCT05660733
- Acronym / sponsor ID
- Repia / Research on existing data
- Conditions
- Aortic Infections and Inflammations, Mycotic Aneurysm, Arterial Infections and Inflammations, Prosthetic Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Dec 2022 (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.
Aortic or large arterial vessel infections are rare but serious infections. Their management is based on French and American expert opinions. The quality of evidence supporting these guidelines is low because most publications on the subject correspond to case series and few interventional studies have been performed to validate their management. However, referral centres for vascular surgery are frequently solicited to give their opinion on patients suffering from mycotic aneurysms. In addition, the last few decades have seen the improvement of vascular surgery techniques allowing the management of more and more patients, often elderly and comorbid. There has therefore been an increase in the incidence of infectious complications associated with this care. It is therefore essential to participate in research on aortic and large arterial vessel infections. For this, a monocentric cohort study seems to be an essential first step to better understand the polymorphism and complexity of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients with proved aortic or large arterial vessel infection and without exclusion criteria.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Aortic or large arterial vessel infection. The diagnosis is made on a number of criteria in favour of the diagnosis (at least 2 of the following 3 criteria):
Key exclusion criteria (6 listed)
- Patient who objected to participation in this protocol and data collection
- Pregnant woman, parturient or breastfeeding mother
- Person deprived of liberty by a judicial or administrative decision,
- Person subject to psychiatric care by virtue of articles L.3212-1 and L.3213-1 of the French public health code
- Person subject to a legal protection measure
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
one-year mortality
Time frame: one year after the diagnosis
Study of all-cause mortality in patients with aortic vascular infection and large arterial vessels during the first year of follow-up after diagnosis.
1 secondary outcome
Identification of prognostic factors associated with arterial vascular infections
Time frame: at the time of diagnosis and up to one year afterwards
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 8 Aug 2025.
- Derived from this study: PubMed 40377031Lalevee L, Serguei M, Jeanbert E, Simon M, Luc A, Settembre N, Henard S, Novy E, Guerci P, Lefevre B. Characteristics and outcomes of patients with infective native aortic aneurysm or vascular graft and endograft infection. Infect Dis (Lond). 2025 Oct;57(10):920-932. doi: 10.1080/23744235.2025.2502826. Epub 2025 May 16.
- Individual participant dataSharing planned: No
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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.
Lefèvre Benjamin, M.D. principal investigator
Université de Lorraine & CHRU de Nancy
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 Aortic Infections and Inflammations and Mycotic Aneurysm, run by Central Hospital, Nancy, France 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Aug 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 Lefèvre Benjamin, M.D. (+33383157654, b.lefevre@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year mortality (time frame: one year after the diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660733, which also lists 1 linked publication.
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 8 Aug 2025.