EndocarditisNATIVTEPNCT03695861
Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves
A study testing Whole-body 18F-FDG PET-CT scan in people with Endocarditis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis
- What is being tested?
- Whole-body 18F-FDG PET-CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2018to 16 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient ≥ 18 years treated at the university hospital center of Bordeaux for suspicion of infectious endocarditis on a native valve with a "definite" or "possible" diagnosis according to the ESC 2015 modified diagnostic criteria, agreeing to participate,
- Affiliated person or beneficiary of a social security scheme,
- Free, informed and written consent (no later than the day of inclusion and before any exam required by the research).
Who cannot join
- Patient with a vital failure (haemodynamic, respiratory or neurological instability), requiring treatment in the intensive care unit and / or urgent surgery incompatible with performing PET-CT,
- Pregnant or nursing woman,
- Patient who has already been treated for infective endocarditis within six months of enrollment,
- Patient who had cardiac surgery in the two months preceding inclusion,
- Patient who has previously been hypersensitive to fluorodeoxyglucose and / or excipients of the radiotracer,
- Patient unable to sign consent,
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- Patient under legal protection,
- Women of childbearing age who do not benefit from effective contraception (HAS criteria),
- Patient in a period of relative exclusion from another research protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).
Read the detailed description
Infectious endocarditis remains a serious pathology with an intra-hospital mortality of between 15 and 30%. The prognosis of patients depends on the speed of diagnosis and the beginning of the appropriate treatment.
Currently, the diagnosis of endocarditis is based on the ESC 2015 modified criteria. Echocardiography techniques play a key role, but can be negative in 20% of endocarditis. 18F-FDG PET-CT showed promising results in the management of prosthetic valve endocarditis and / or stimulation material.
However, few studies have been carried out on the contribution of PET-CT in the diagnosis of endocarditis on native valves, with discordant results. But this is the majority of endocarditis (70% of cases).
A 18F-FDG PET-CT will be performed in all patients included in the study in addition to standard care for endocarditis, within 5 days of the beginning of their management in the university hospital center of Bordeaux after verification of inclusion and exclusion criteria and signature of consent.
The included patients will be reviewed at Month 3 during a consultation with the completion of a clinical examination, an electrocardiogram, a biological assessment and a transthoracic ultrasound.
Adverse events and serious adverse events will be collected throughout the study.
- Conditions
- Endocarditis
- Being tested
- Whole-body 18F-FDG PET-CT scan
- Keywords
- Endocarditis Infectious, Native valve, ESC 2015 modified diagnostic criteria, 18F-FDG PET-CT, Detection of peripheral emboli
- Medical subject headings
- Endocarditis, Endocarditis, Subacute Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body 18F-FDG PET-CT scanDiagnostic test
A 18F-FDG PET-CT will be performed within 5 days of the beginning of the patients care with infectious endocarditis at the University Hospital center of Bordeaux.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body 18F-FDG PET-CT scan | Experimental | Not described Receives: Diagnostic Test: Whole-body 18F-FDG PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis
The reference test in this study will be a "definite diagnosis" of infectious endocarditis according to the ESC 2015 modified criteria at three months of follow-up, evaluated by a multidisciplinary committee in infectious endocarditis. This evaluation will be done blind to the results of the PET-CT of the study. The index test 18F-FDG PET-CT will have been performed at the initial phase of patient management.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start10 Nov 2018
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic study, prospective, "delayed-type cross-sectional study" (the result of the reference test is defined at 3 months of follow-up), monocentric, blinded, including consecutive patients.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile ALEXANDRINO, MD, Principal investigator, University Hospital, BordeauxPaul PEREZ, MD,PhD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695861
- Sponsor's protocol ID
- CHUBX 2017/33
- Other IDs
- 2018-A00134-51
- Acronym
- NATIVTEP
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves
- ClinicalTrials.gov ID
- NCT03695861
- Acronym / sponsor ID
- NATIVTEP / CHUBX 2017/33
- Conditions
- Endocarditis
- Keywords
- Endocarditis Infectious, Native valve, ESC 2015 modified diagnostic criteria, 18F-FDG PET-CT, Detection of peripheral emboli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).
Detailed description
Infectious endocarditis remains a serious pathology with an intra-hospital mortality of between 15 and 30%. The prognosis of patients depends on the speed of diagnosis and the beginning of the appropriate treatment.
Currently, the diagnosis of endocarditis is based on the ESC 2015 modified criteria. Echocardiography techniques play a key role, but can be negative in 20% of endocarditis. 18F-FDG PET-CT showed promising results in the management of prosthetic valve endocarditis and / or stimulation material.
However, few studies have been carried out on the contribution of PET-CT in the diagnosis of endocarditis on native valves, with discordant results. But this is the majority of endocarditis (70% of cases).
A 18F-FDG PET-CT will be performed in all patients included in the study in addition to standard care for endocarditis, within 5 days of the beginning of their management in the university hospital center of Bordeaux after verification of inclusion and exclusion criteria and signature of consent.
The included patients will be reviewed at Month 3 during a consultation with the completion of a clinical examination, an electrocardiogram, a biological assessment and a transthoracic ultrasound.
Adverse events and serious adverse events will be collected throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic study, prospective, "delayed-type cross-sectional study" (the result of the reference test is defined at 3 months of follow-up), monocentric, blinded, including consecutive patients.
| Arm | Type | Receives |
|---|---|---|
| Whole-body 18F-FDG PET-CT scan | Experimental | Diagnostic Test: Whole-body 18F-FDG PET-CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient ≥ 18 years treated at the university hospital center of Bordeaux for suspicion of infectious endocarditis on a native valve with a "definite" or "possible" diagnosis according to the ESC 2015 modified diagnostic criteria, agreeing to participate,
- Affiliated person or beneficiary of a social security scheme,
- Free, informed and written consent (no later than the day of inclusion and before any exam required by the research).
Key exclusion criteria (9 listed)
- Patient with a vital failure (haemodynamic, respiratory or neurological instability), requiring treatment in the intensive care unit and / or urgent surgery incompatible with performing PET-CT,
- Pregnant or nursing woman,
- Patient who has already been treated for infective endocarditis within six months of enrollment,
- Patient who had cardiac surgery in the two months preceding inclusion,
- Patient who has previously been hypersensitive to fluorodeoxyglucose and / or excipients of the radiotracer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body 18F-FDG PET-CT scanA 18F-FDG PET-CT will be performed within 5 days of the beginning of the patients care with infectious endocarditis at the University Hospital center of Bordeaux. | Diagnostic test | Whole-body 18F-FDG PET-CT scan |
Primary outcome
Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis
Time frame: 3 month
The reference test in this study will be a "definite diagnosis" of infectious endocarditis according to the ESC 2015 modified criteria at three months of follow-up, evaluated by a multidisciplinary committee in infectious endocarditis. This evaluation will be done blind to the results of the PET-CT of the study. The index test 18F-FDG PET-CT will have been performed at the initial phase of patient management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile ALEXANDRINO, MD principal investigator
University Hospital, Bordeaux
Paul PEREZ, MD,PhD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body 18F-FDG PET-CT scan in people with Endocarditis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.