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NCT Number: NCT05989152

Evolution of PET Fixation With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

"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."

Treatment and study plan

FDG-PET at the end of treatment for IE

Radiation

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

Primary outcomes

  1. Presence of pathological uptake on the prosthetic valve on FDG-PET

    Time frame: at inclusion

    Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment

Secondary outcomes

  1. Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET

    Time frame: at inclusion

    by comparing the FDG uptake intensity on the prosthetic valve between initial and at the end of curative antibiotic treatment FDG-PET

  2. 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

    Time frame: at inclusion

    by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment

  3. 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

    Time frame: at inclusion

    by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment

  4. Relapse of endocarditis defined by the same location and the same microorganism within 6 months

    Time frame: 6 month

  5. Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment

    Time frame: 6 month

    measured by stopping or continuing antibiotic treatment

  6. Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months

    Time frame: 6 month

    classification

Study contacts

Contact information is provided by the study sponsor or research team.

François Rouzet, MD, PHD

CONTACT

[email protected]

01.40.25.64.11 ext. 33

Xavier Duval, MD, PHD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EndEOTEP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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