VIP - Vascular Infection Project (Cohorte VIP)

March 5, 2025 updated by: University Hospital, Bordeaux

VIP - Vascular Infection Project : Prospective Multicentric Database on Vascular Infections

Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize these infections

Study Overview

Status

Recruiting

Conditions

Detailed Description

Vascular infections are rare but severe, burdened by high morbi-mortality and recurrence rates. However, many questions remain regarding their management which is still not consensual, both surgical and medical management. The term "vascular infections" encompasses vascular graft and endograft infections, as well as infections of native arteries and the aorta. For vascular graft infections, the optimal surgery is to remove the infected graft before vascular reconstruction with a new graft, either synthetic or biologic. However, some patients are too fragile to undergo surgery and might then benefit from an endovascular graft, an abscess drainage or no surgery at all, only medical treatment. For native arterial infections, surgery is often required to remove the infected arterial wall before vascular reconstruction. However, some patients cannot be operated on and might also benefit from an endovascular surgery. In these two vascular infections, the ideal anti-microbial treatment is uncertain, whether it pertains to the duration of therapy, the type of molecules, or their number. All of these medical and surgical factors may impact the prognosis of patients and should be collectively assessed in order to determine the best strategy for enhancing their outcomes.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ents with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent)

Description

Inclusion Criteria:

  • ≥ 18 years-old;
  • all patients with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent),
  • oral consent

Exclusion Criteria:

  • patient under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Native vascular infection
Prosthetic vascular infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: Year 1
mortality r
Year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: Day 30, Year 2, Year 5
mortality rate
Day 30, Year 2, Year 5
morbidity
Time Frame: Year 1
morbidity rate
Year 1
relapse
Time Frame: year 1, Year 2, Year 5
relapse rates
year 1, Year 2, Year 5
reinfection
Time Frame: year 1, Year 2, Year 5
reinfection rates
year 1, Year 2, Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Estimated)

May 10, 2032

Study Completion (Estimated)

May 10, 2032

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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