NCT05989152

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

May 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 17, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

May 24, 2023

Last Update Submit

July 31, 2025

Conditions

Prosthetic Valve Endocarditis

Keywords

Infective endocarditisend of treatmentPositron emission tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Evolution of the FDG uptake intensity on the prosthetic valve by 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

    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

    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

    6 month

  • +1 more secondary outcomes

Study Arms (1)

Definite prosthetic valve endocarditis

EXPERIMENTAL

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

Interventions

FDG-PET at the end of treatment for IERADIATION

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

Definite prosthetic valve endocarditis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, France, 75018, France

RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • François Rouzet, MD, PHD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Rouzet, MD, PHD

CONTACT

01.40.25.64.11francois.rouzet@aphp.fr

Xavier Duval, MD, PHD

CONTACT

xavier.duval@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

August 14, 2023

Study Start

April 17, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 5, 2025

Record last verified: 2025-07

Locations

FR(1)