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

Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis

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.

Study Overview

• Status: Recruiting
• Conditions: Prosthetic Valve Endocarditis
• Intervention / Treatment: Radiation: FDG-PET at the end of treatment for IE

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François Rouzet, MD, PHD; Phone Number: 33 01.40.25.64.11; Email: francois.rouzet@aphp.fr
• Study Contact Backup: Name: Xavier Duval, MD, PHD; Email: xavier.duval@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Recruiting
    • Hopital Bichat-Claude Bernard
    • Contact: François Rouzet, MD, PHD; Phone Number: 33 01.40.25.64.11; Email: francois.rouzet@aphp.fr
    • Contact: Xavier Duval, MD, PHD; Email: xavier.duval@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

"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."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Definite prosthetic valve endocarditis; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pathological uptake on the prosthetic valve on FDG-PET	Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment	at inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: François Rouzet, MD, PHD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Infective endocarditis; Positron emission tomography; end of treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis; Endocarditis, Bacterial
• Other Study ID Numbers: APHP230123; 2022-A02782-41 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No