Clinical trial NCT05660733: Study of the Aortic and Large Arterial Vessel Infections
Official title: French Registry Studying the Characteristics and Prognosis of Aortic and Large Arterial Vessel Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Infections and Inflammations
Mycotic Aneurysm
Arterial Infections and Inflammations
Prosthetic Infection
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults patients with proved aortic or large arterial vessel infection and without exclusion criteria.

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.


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

Primary outcomes:
measure: one-year mortality
timeFrame: one year after the diagnosis
Secondary outcomes:
measure: Identification of prognostic factors associated with arterial vascular infections
timeFrame: at the time of diagnosis and up to one year afterwards
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Université de Lorraine, CHRU Nancy and APEMAC
state: Lorraine
Study officials:
affiliation: Université de Lorraine & CHRU de Nancy
name: Lefèvre Benjamin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: