Study of the Aortic and Large Arterial Vessel Infections (NCT05660733) | Clinical Trial Compass
RecruitingNot Applicable
Study of the Aortic and Large Arterial Vessel Infections
France500 participantsStarted 2023-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.