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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Definite prosthetic valve endocarditisExperimental treatment 1 intervention

Trial outcomes

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

Time frame
at inclusion

Secondary outcomes

1

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

Time frame
at inclusion
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

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

Time frame
at inclusion
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

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

Time frame
at inclusion
4

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

Time frame
6 month

Other outcomes

Sponsors and contacts

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