Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05989152

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-05

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with prosthetic valve endocarditis (PVE) who have shown abnormal FDG uptake on initial FDG-PET scans and were not referred for valve replacement surgery during the acute phase. This study aims to determine if FDG-PET can identify those at higher risk of PVE relapse after antibiotic treatment. The goal is to improve patient management by identifying persistent infection or cure, which could guide decisions on surgery, suppressive antibiotic therapy, or follow-up strategies. The study involves a single-center prospective cohort of 50 adults with definite PVE based on ESC 2015 criteria. Participants have pathological FDG uptake on the prosthetic valve at the start of antibiotic treatment and are medically treated without acute phase surgery. FDG-PET scans are performed at the end of antibiotic treatment to assess changes in valvular and extracardiac FDG uptake. The study also evaluates artificial intelligence analysis to predict relapse risk. Participants will undergo FDG-PET imaging before and after curative antibiotic treatment. Researchers will measure valvular and extracardiac FDG uptake intensity and monitor for PVE relapse within six months. The study will assess the impact of end-of-treatment PET-FDG findings on antibiotic therapy decisions. Follow-up includes clinical monitoring for relapse, with data collected on antibiotic treatment duration and diagnostic accuracy of AI prediction methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 or over
  • Have a prosthetic valve implanted surgically or by catheter for at least 3 months
  • Presenting a definite infective endocarditis on a prosthetic valve according to ESC definition
  • Having undergone an FDG-PET exam showing pathological hyperuptake on the prosthetic valve within 15 days after starting antibiotic therapy
  • No cardiac surgery performed or planned before the end-of-treatment FDG-PET
Not Eligible

You will not qualify if you...

  • Patient under legal protection, guardianship, or curatorship
  • Pregnancy or breastfeeding
  • Not affiliated with a health insurance or social security scheme
  • Simultaneous participation in another FDG-PET study
  • Absence of signed informed consent by the patient

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of antibiotic treatment as prescribed

Participants undergo curative antibiotic treatment for prosthetic valve infective endocarditis.

Visits occur as part of routine care; specific visit schedule not defined in the trial

FDG-PET Evaluation at End of Treatment

Duration - Within 15 days after completing antibiotic treatment

Participants undergo an FDG-PET scan at the end of antibiotic treatment to assess valvular and extracardiac FDG uptake.

1 visit (in-person) for FDG-PET scan

Follow-up Monitoring

Duration - 6 months

Participants are monitored for up to 6 months after treatment to evaluate for relapse of endocarditis and therapeutic outcomes.

Follow-up visits as per clinical practice; specific schedule not defined in the trial

Trial Site Locations

Total: 1 location

1

Hôpital Bichat-Claude Bernard

Paris, France, France, 75018

Actively Recruiting

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Research Team

F

François Rouzet, MD, PHD

X

Xavier Duval, MD, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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