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

NCT ID: NCT05989152

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2027-12-31

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."

Conditions

Prosthetic Valve Endocarditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FDG-PET at the end of treatment for IE

Intervention Type: RADIATION

FDG-PET at the end of treatment for IE in patients with a prosthetic valve

Interventions

FDG-PET at the end of treatment for IE

FDG-PET at the end of treatment for IE in patients with a prosthetic valve

Intervention Type: RADIATION

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Rouzet, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat-Claude Bernard

Paris, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

François Rouzet, MD, PHD

Role: CONTACT

francois.rouzet@aphp.fr

01.40.25.64.11 ext. 33

Xavier Duval, MD, PHD

Role: CONTACT

xavier.duval@aphp.fr

Facility Contacts

François Rouzet, MD, PHD

Role: primary

francois.rouzet@aphp.fr

01.40.25.64.11 ext. 33

Xavier Duval, MD, PHD

Role: backup

xavier.duval@aphp.fr

Other Identifiers

2022-A02782-41

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230123

Identifier Type: -

Identifier Source: org_study_id