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Clinical Trials/NCT05660733
NCT05660733
Recruiting
Not Applicable

French Registry Studying the Characteristics and Prognosis of Aortic and Large Arterial Vessel Infections

Central Hospital, Nancy, France1 site in 1 country500 target enrollmentJune 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Infections and Inflammations
Sponsor
Central Hospital, Nancy, France
Enrollment
500
Locations
1
Primary Endpoint
one-year mortality
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2023
End Date
January 1, 2027
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

LEFEVRE Benjamin

Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Identification of prognostic factors associated with arterial vascular infections(at the time of diagnosis and up to one year afterwards)

Study Sites (1)

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