Study of the Aortic and Large Arterial Vessel Infections

Prosthetic Infection Clinical Trial

— Repia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660733
• Other study ID #: Research on existing data
• Status: Recruiting
• Start date: June 30, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: Central Hospital, Nancy, France
• Contact: Lefèvre Benjamin, M.D.
• Phone: +33383157654
• Email: b.lefevre[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Communicable Diseases
• Infections
• Inflammation
• Prosthetic Infection

Locations

Country	Name	City	State
France	Université de Lorraine, CHRU Nancy and APEMAC	Vandoeuvre Les Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identification of prognostic factors associated with arterial vascular infections	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