Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FDG-PET at the end of treatment for IE.
- Who it may be relevant to
- Registry conditions: Prosthetic Valve Endocarditis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
Overview
In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the study will assess whether FDG-PET is able to identify those at increased risk of PVE relapse.
Detailed description
In patients medically treated for prosthetic valve infection (PVE), identification of persistent infection or of cure could be very useful to 1/ patients referral to high-risk surgery, 2/ initiation of suppressive antibiotic therapy, or 3/ simplify the follow-up in other patients. The hypothesis is that FDG-PET could thus identify patients at increased risk of recurrence in case of persistent pathological uptake In patients with prosthetic endocarditis and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the main objective is to estimate the proportion of those still showing pathological valvular FDG uptake after curative antibiotic treatment. The secondary objectives are 1/ to quantitatively compare the valvular FDG-PET uptake for each individual before and after treatment; 2/ to determine the proportion of those in whom extracardiac foci persist at the end of treatment ; 3/ to evaluate the association between valvular FDG uptake on PET at the end of treatment and PVE relapse at 6 months; 4/ to evaluate the diagnostic performance of an automatic analysis by artificial intelligence of FDG uptake before and after treatment to predict PVE relapse at 6 months.
This is a single-center prospective cohort study. The population is composed of 50 adults with definite PVE according to the ESC 2015 classification, not operated in the acute phase and with pathological FDG-PET at the beginning of curative antibiotic treatment.
A change in practices regarding the duration of antibiotic therapy and the use of valve replacement surgery and its potential complications would benefit patients and reduce the overall cost related to valve prosthesis infection to the healthcare system."
Interventions
- Radiation FDG-PET at the end of treatment for IE
FDG-PET at the end of treatment for IE in patients with a prosthetic valve
Primary outcome measures
- Presence of pathological uptake on the prosthetic valve on FDG-PET [Time frame: at inclusion]
Secondary outcome measures (6)
- Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET [Time frame: at inclusion]
- Presence of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET [Time frame: at inclusion]
- Evolution of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET [Time frame: at inclusion]
- Relapse of endocarditis defined by the same location and the same microorganism within 6 months [Time frame: 6 month]
- Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment [Time frame: 6 month]
- Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months [Time frame: 6 month]
Eligibility criteria
"Inclusion criteria:
- Patient aged 18 or over;
- Have a prosthetic valve implanted surgically or by catheter for at least 3 months;
- Presenting a definite IE on a prosthetic valve (ESC definition in force);
- Having benefited from an FDG-PET examination for diagnostic purposes as part of the treatment revealing pathological hyperuptake at the level of the prosthetic valve AND carried out <15 days after the start of antibiotic therapy for infective endocarditis;
- Absence of cardiac surgical intervention performed for the current episode of AE or planned before the end-of-treatment FDG-PET
Exclusion criteria
- Patient under legal protection, guardianship or curators;
- Pregnancy, breastfeeding;
- Patient not affiliated to a health insurance scheme or not a beneficiary of a social security scheme;
- Simultaneous participation in a study on FDG-PET;
- Absence of informed consent signed by the patient."
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpital Bichat-Claude Bernard — Paris
Identifiers
NCT: NCT05989152 · APHP230123 · 2022-A02782-41