- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05660733
Study of the Aortic and Large Arterial Vessel Infections (Repia)
August 6, 2025 updated by: LEFEVRE Benjamin, Central Hospital, Nancy, France
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
500
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
- Name: Lefevre Benjamin, M.D.
- Phone Number: +33383157654
- Email: b.lefevre@chru-nancy.fr
Study Locations
-
-
Lorraine
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Vandoeuvre Les Nancy, Lorraine, France, 54511
- Recruiting
- Université de Lorraine, CHRU Nancy and APEMAC
-
Contact:
- Lefevre Benjamin, M.D.
- Phone Number: +33383157654
- Email: b.lefevre@chru-nancy.fr
-
-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All adults patients with proved aortic or large arterial vessel infection and without exclusion criteria.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one year after the diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of prognostic factors associated with arterial vascular infections
Time Frame: at the time of diagnosis and up to one year afterwards
|
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
|
at the time of diagnosis and up to one year afterwards
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lefèvre Benjamin, M.D., Université de Lorraine & CHRU de Nancy
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)
June 30, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
December 7, 2022
First Submitted That Met QC Criteria
December 19, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
August 8, 2025
Last Update Submitted That Met QC Criteria
August 6, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Research on existing data
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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