Aortic Infections and InflammationsNCT05521035
Risk and Incidence of Aortic Graft and Endograft Infection With BSI
An observational study of Aortic Infections and Inflammations, run by Lund University at 1 site in Sweden.
Trial summary
What is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Infections and Inflammations
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with previous aortic vascular graft or endograft surgery in Skåne, Halland, Kronoberg and Blekinge between the years 2010-2021.
Who may be able to join
- Previous aortic vascular graft or endograft infection with bloodstream infection.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Torgny Sunnerhagen, M.D, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Helsingborgs lasarett
Helsingborg
Adam Cewers
About this study
Official title: Risk and Incidence of Aortic Graft and Endograft Infection in Patients With Bloodstream Infection, a Population Based Study in South Sweden
What is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection?
Read the detailed description
All patients with previous aortic vascular graft and endograft surgery between years 2010 and 2021 in four regions of south Sweden (Skåne, Halland, Kronoberg and Blekinge) will be included in the study. These patients will be evaluated for bloodstream infection (BSI) or not. For all patients with BSI, the risk of aortic vascular graft and endograft infection will be investigated. Aortic vascular graft and endograft infection will be determined by usage of the MAGIC-criteria.
Risk factors for developing aortic vascular graft and endograft infection will be investigated, and if possible used to construct a risk score. This risk score could be used by clinicians to determine if bacteremic patients with aortic vascular grafts or endografts should be evaluated for aortic vascular graft and endograft infection.
- Conditions
- Aortic Infections and Inflammations
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic vascular graft or endograft infection
Determined by the MAGIC-criteria
Measured: At least 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Infections and InflammationsStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oskar Ljungquist, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521035
- Sponsor's protocol ID
- 2022-5-BSI
- Status last verified
- Dec 2023
- First submitted
- 26 Aug 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If individual participant data (IPD) will be shared, it will be after researchers has been given ethical approval
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Incidence of Aortic Graft and Endograft Infection in Patients With Bloodstream Infection, a Population Based Study in South Sweden
- ClinicalTrials.gov ID
- NCT05521035
- Acronym / sponsor ID
- 2022-5-BSI
- Conditions
- Aortic Infections and Inflammations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection?
Detailed description
All patients with previous aortic vascular graft and endograft surgery between years 2010 and 2021 in four regions of south Sweden (Skåne, Halland, Kronoberg and Blekinge) will be included in the study. These patients will be evaluated for bloodstream infection (BSI) or not. For all patients with BSI, the risk of aortic vascular graft and endograft infection will be investigated. Aortic vascular graft and endograft infection will be determined by usage of the MAGIC-criteria.
Risk factors for developing aortic vascular graft and endograft infection will be investigated, and if possible used to construct a risk score. This risk score could be used by clinicians to determine if bacteremic patients with aortic vascular grafts or endografts should be evaluated for aortic vascular graft and endograft infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with previous aortic vascular graft or endograft surgery in Skåne, Halland, Kronoberg and Blekinge between the years 2010-2021.
Key inclusion criteria (1 listed)
- Previous aortic vascular graft or endograft infection with bloodstream infection.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aortic vascular graft or endograft infection
Time frame: At least 1 year follow-up
Determined by the MAGIC-criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Treatment and outcomes of aortic endograft infectionLink provided by the sponsor.
- Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC)Link provided by the sponsor.
- Secondary infections of thoracic and abdominal aortic endograftsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. If individual participant data (IPD) will be shared, it will be after researchers has been given ethical approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torgny Sunnerhagen, M.D, PhD contact
Oskar Ljungquist principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Infections and Inflammations, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oskar Ljungquist, M.D, PhD (+46424061000, oskar.ljungquist@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic vascular graft or endograft infection (time frame: At least 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.