Study of the Aortic and Large Arterial Vessel Infections

Recruiting

• Conditions: Mycotic Aneurysm; Arterial Infections and Inflammations; Aortic Infections and Inflammations; Prosthetic Infection

• Registration Number: NCT05660733
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-21
• Study Start: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
one-year mortality	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.

Secondary Outcome Measures

Name	Time	Method
Identification of prognostic factors associated with arterial vascular infections	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

Trial Locations

Locations (1)

Université de Lorraine, CHRU Nancy and APEMAC; 🇫🇷 Vandoeuvre Les Nancy, Lorraine, France