Study of the Aortic and Large Arterial Vessel Infections

NCT05660733 | Recruiting

• 1 other identifier: Research on existing data
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  one year after the diagnosis

Secondary Outcomes (1)

• Identification of prognostic factors associated with arterial vascular infections

  at the time of diagnosis and up to one year afterwards

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults patients with proved aortic or large arterial vessel infection and without exclusion criteria.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Université de Lorraine, CHRU Nancy and APEMAC

Vandœuvre-lès-Nancy, Lorraine, 54511, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 40377031 DERIVED

MeSH Terms

Conditions

Inflammation; Aneurysm, Infected

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lefèvre Benjamin, M.D.

  Université de Lorraine & CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lefèvre Benjamin, M.D.

CONTACT

+33383157654; b.lefevre@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 21, 2022
• Study Start: June 30, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)