Hôpital Bichat-Claude Bernard
Paris, France, 75018
Location status: Recruiting
NCT Number: NCT05989152
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, France, 75018
Location status: Recruiting
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."
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
"Inclusion criteria:
Exclusion criteria
FDG-PET at the end of treatment for IE in patients with a prosthetic valve
Time frame: at inclusion
Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment
Time frame: at inclusion
by comparing the FDG uptake intensity on the prosthetic valve between initial and at the end of curative antibiotic treatment FDG-PET
Time frame: at inclusion
by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
Time frame: at inclusion
by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
Time frame: 6 month
Time frame: 6 month
measured by stopping or continuing antibiotic treatment
Time frame: 6 month
classification
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
Acronym: EndEOTEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07253688
Prosthetic Valve Endocarditis, Staphylococcus Aureus Endocarditis
Montreal, Quebec, Canada
View Trial DetailsNCT07345325
Bacterial Infections, Bacterial Infections and Mycoses
Aix-les-Bains, France
View Trial DetailsNCT05721781
Bacteremia, Bacterial Infections
Boston, Massachusetts, United States
View Trial DetailsNCT06434012
Bacterial Infections, Bacterial Infections and Mycoses
London, United Kingdom
View Trial Details