Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis

Not Applicable

Not yet recruiting

• Conditions: Prosthetic Valve Endocarditis
• Interventions: Radiation: FDG-PET at the end of treatment for IE

• Registration Number: NCT05989152
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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."

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Study Start: 2024-09
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definite prosthetic valve endocarditis	FDG-PET at the end of treatment for IE	adult patients with a valvular prosthesis presenting a definite infective endocarditis (IE) according to the ESC classification in force, not operated on in the acute phase (before the PET scan at the end of treatment) and presenting a pathological FDG uptake on the prosthetic valve at the start of curative antibiotic treatment.

Primary Outcome Measures

Name	Time	Method
Presence of pathological uptake on the prosthetic valve on FDG-PET	at inclusion	Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment

Secondary Outcome Measures

Name	Time	Method
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	at inclusion	by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
Relapse of endocarditis defined by the same location and the same microorganism within 6 months	6 month
Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET	at inclusion	by comparing the FDG uptake intensity on the prosthetic valve between initial and at the end of curative antibiotic treatment FDG-PET
Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment	6 month	measured by stopping or continuing antibiotic treatment
Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months	6 month	classification
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	at inclusion	by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment

Trial Locations

Locations (1)

Hôpital Bichat-Claude Bernard; 🇫🇷 Paris, France