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

Primary Purpose

Prosthetic Valve Endocarditis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FDG-PET at the end of treatment for IE
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prosthetic Valve Endocarditis focused on measuring Infective endocarditis, end of treatment, Positron emission tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

"Inclusion criteria: Patient aged 18 or over; Wearer of a valvular prosthesis (implanted surgically or by catheter); Presenting a definite IE on a valvular prosthesis (ESC definition in force); Abnormal FDG-PET scan for diagnostic purposes at the site of the valvular prosthesis; Not operated at in the acute phase (before the PET scan at the end of treatment) 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."

Sites / Locations

  • Hôpital Bichat-Claude Bernard

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Definite prosthetic valve endocarditis

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Relapse of endocarditis defined by the same location and the same microorganism within 6 months
Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment
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
classification

Full Information

First Posted
May 24, 2023
Last Updated
August 2, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05989152
Brief Title
Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
Acronym
EndEOTEP
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Valve Endocarditis
Keywords
Infective endocarditis, end of treatment, Positron emission tomography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Definite prosthetic valve endocarditis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
FDG-PET at the end of treatment for IE
Intervention Description
FDG-PET at the end of treatment for IE in patients with a prosthetic valve
Primary Outcome Measure Information:
Title
Presence of pathological uptake on the prosthetic valve on FDG-PET
Description
Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET
Description
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
Title
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
Description
by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
Time Frame
at inclusion
Title
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
Description
by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
Time Frame
at inclusion
Title
Relapse of endocarditis defined by the same location and the same microorganism within 6 months
Time Frame
6 month
Title
Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment
Description
measured by stopping or continuing antibiotic treatment
Time Frame
6 month
Title
Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months
Description
classification
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
"Inclusion criteria: Patient aged 18 or over; Wearer of a valvular prosthesis (implanted surgically or by catheter); Presenting a definite IE on a valvular prosthesis (ESC definition in force); Abnormal FDG-PET scan for diagnostic purposes at the site of the valvular prosthesis; Not operated at in the acute phase (before the PET scan at the end of treatment) 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."
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Rouzet, MD, PHD
Phone
01.40.25.64.11
Ext
33
Email
francois.rouzet@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Duval, MD, PHD
Email
xavier.duval@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Rouzet, MD, PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Rouzet, MD, PHD
Phone
01.40.25.64.11
Ext
33
Email
francois.rouzet@aphp.fr
First Name & Middle Initial & Last Name & Degree
Xavier Duval, MD, PHD
Email
xavier.duval@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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