Infective EndocarditisTEPvENDONCT02287792
18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis
A study testing 18-FDG PET/CT scan in people with Infective Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- 18-FDG PET/CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2015to Jan 2017
- 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
- Subjects aged ≥ 18 years
- Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
- Transthoracic or transesophageal ultrasound performed.
- A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
- Absence of cardiac surgery for the current IE episode
- Covered by the French health insurance system
- Having given and signed the written study informed consent to the study.
Who cannot join
- Patient having already had a 18-FDG PET/CT in the current episode
- Contraindication to perform a 18-FDG PET/CT
- Early prosthetic valve IE (cardiac surgery within last 2 months)
- Inability to understand the information form
- Pregnant or lactating woman.
- Cardiac surgery between inclusion and 18-FDG PET/CT
- Participation to any clinical trial including 18-FDG PET/CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study
The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Read the detailed description
Introduction:
Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.
18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.
Hypothesis:
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
Primary objective:
To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.
Secondary objectives:
- To evaluate the impact of 18-FDG PET/CT on the Duke-Li criteria for IE diagnosis
- To evaluate the performance of 18-FDG PET/CT in detecting valve damages and extracardiac complications induced by the IE
- To evaluate whether 18-FDG PET/CT may help identify the infection's portal of entry
- To evaluate whether the detection of extracardiac complications by FDG PET/CT is associated with the 6-months survival rate
- To identify clinical and biological determinants of extracardiac IE localizations and prognosis
- To determine the inter-reader interpretation of the18-FDG PET/CT results and the reproducibility in preparation and acquisition method
- Conditions
- Infective Endocarditis
- Being tested
- 18-FDG PET/CT scan
- Keywords
- Infective endocarditis, 18-FDG PET/CT, Impact, Patient's management, Diagnostic
- Medical subject headings
- Endocarditis, Tooth, Impacted, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-FDG PET/CT scanProcedure or surgery
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
| Study group | Role | What they receive |
|---|---|---|
| 18-FDG PET/CT scan | Experimental | All patients will undergo a whole body PET/CT scan Receives: Procedure: 18-FDG PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a change in IE therapeutic plan
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
Measured: 7 days
Secondary outcomes (5)
Proportion of patients with Duke-Li classification modifications
Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification
Measured: 6 months
Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures
1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE
Measured: 6 months
6-month mortality rate
number of dead patients 6 months after inclusion
Measured: 6 months
Determinants of change in therapeutic plan as defined in primary outcome
Clinical and biological determinants of therapeutic changes
Measured: 6 months
18-FDG PET/CT inter-reader reproducibility
questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study start17 Apr 2015
- Primary completionApr 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Duval, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287792
- Sponsor's protocol ID
- AOM13549
- Acronym
- TEPvENDO
- Status last verified
- Jul 2017
- First submitted
- 31 Oct 2014
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Boursier C, Duval X, Bourdon A, Imbert L, Mahida B, Chevalier E, Claudin M, Hoen B, Goehringer F, Selton-Suty C, Roch V, Lamiral Z, Humbert O, Rouzet F, Marie PY; AEPEI-TEPvENDO study group. ECG-Gated Cardiac FDG PET Acquisitions Significantly Improve Detectability of Infective Endocarditis. JACC Cardiovasc Imaging. 2020 Dec;13(12):2691-2693. doi: 10.1016/j.jcmg.2020.06.036. Epub 2020 Aug 19. No abstract available.
PubMed 32828775Duval X, Le Moing V, Tubiana S, Esposito-Farese M, Ilic-Habensus E, Leclercq F, Bourdon A, Goehringer F, Selton-Suty C, Chevalier E, Boutoille D, Piriou N, Le Tourneau T, Chirouze C, Seronde MF, Morel O, Piroth L, Eicher JC, Humbert O, Revest M, Thebault E, Devillers A, Delahaye F, Boibieux A, Gregoire B, Hoen B, Laouenan C, Iung B, Rouzet F; AEPEI-TEPvENDO study group. Impact of Systematic Whole-body 18F-Fluorodeoxyglucose PET/CT on the Management of Patients Suspected of Infective Endocarditis: The Prospective Multicenter TEPvENDO Study. Clin Infect Dis. 2021 Aug 2;73(3):393-403. doi: 10.1093/cid/ciaa666.
PubMed 32488236Boursier C, Duval X, Mahida B, Hoen B, Goehringer F, Selton-Suty C, Chevalier E, Roch V, Lamiral Z, Bourdon A, Piriou N, Pallardy A, Morel O, Rouzet F, Marie PY; AEPEI-TEPvENDO Study Group. Hypermetabolism of the spleen or bone marrow is an additional albeit indirect sign of infective endocarditis at FDG-PET. J Nucl Cardiol. 2021 Dec;28(6):2533-2542. doi: 10.1007/s12350-020-02050-2. Epub 2020 Feb 10.
PubMed 32043240
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study
- ClinicalTrials.gov ID
- NCT02287792
- Acronym / sponsor ID
- TEPvENDO / AOM13549
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis, 18-FDG PET/CT, Impact, Patient's management, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Nov 2014 (estimated)
- 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 purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Detailed description
Introduction:
Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.
18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.
Hypothesis:
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
Primary objective:
To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.
Secondary objectives:
- To evaluate the impact of 18-FDG PET/CT on the Duke-Li criteria for IE diagnosis
- To evaluate the performance of 18-FDG PET/CT in detecting valve damages and extracardiac complications induced by the IE
- To evaluate whether 18-FDG PET/CT may help identify the infection's portal of entry
- To evaluate whether the detection of extracardiac complications by FDG PET/CT is associated with the 6-months survival rate
- To identify clinical and biological determinants of extracardiac IE localizations and prognosis
- To determine the inter-reader interpretation of the18-FDG PET/CT results and the reproducibility in preparation and acquisition method
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-FDG PET/CT scan | Experimental | Procedure: 18-FDG PET/CT scanAll patients will undergo a whole body 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 (7 listed)
- Subjects aged ≥ 18 years
- Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
- Transthoracic or transesophageal ultrasound performed.
- A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
- Absence of cardiac surgery for the current IE episode
Key exclusion criteria (7 listed)
- Patient having already had a 18-FDG PET/CT in the current episode
- Contraindication to perform a 18-FDG PET/CT
- Early prosthetic valve IE (cardiac surgery within last 2 months)
- Inability to understand the information form
- Pregnant or lactating woman.
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 |
|---|---|---|
| 18-FDG PET/CT scanWhole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis | Procedure or surgery | 18-FDG PET/CT scan |
Primary outcome
Proportion of patients with a change in IE therapeutic plan
Time frame: 7 days
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
5 secondary outcomes
Proportion of patients with Duke-Li classification modifications
Time frame: 6 months
Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures
Time frame: 6 months
6-month mortality rate
Time frame: 6 months
Determinants of change in therapeutic plan as defined in primary outcome
Time frame: 6 months
18-FDG PET/CT inter-reader reproducibility
Time frame: 6 months
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 8 Aug 2025.
- Results publication: PubMed 32828775Boursier C, Duval X, Bourdon A, Imbert L, Mahida B, Chevalier E, Claudin M, Hoen B, Goehringer F, Selton-Suty C, Roch V, Lamiral Z, Humbert O, Rouzet F, Marie PY; AEPEI-TEPvENDO study group. ECG-Gated Cardiac FDG PET Acquisitions Significantly Improve Detectability of Infective Endocarditis. JACC Cardiovasc Imaging. 2020 Dec;13(12):2691-2693. doi: 10.1016/j.jcmg.2020.06.036. Epub 2020 Aug 19. No abstract available.
- Results publication: PubMed 32488236Duval X, Le Moing V, Tubiana S, Esposito-Farese M, Ilic-Habensus E, Leclercq F, Bourdon A, Goehringer F, Selton-Suty C, Chevalier E, Boutoille D, Piriou N, Le Tourneau T, Chirouze C, Seronde MF, Morel O, Piroth L, Eicher JC, Humbert O, Revest M, Thebault E, Devillers A, Delahaye F, Boibieux A, Gregoire B, Hoen B, Laouenan C, Iung B, Rouzet F; AEPEI-TEPvENDO study group. Impact of Systematic Whole-body 18F-Fluorodeoxyglucose PET/CT on the Management of Patients Suspected of Infective Endocarditis: The Prospective Multicenter TEPvENDO Study. Clin Infect Dis. 2021 Aug 2;73(3):393-403. doi: 10.1093/cid/ciaa666.
- Results publication: PubMed 32043240Boursier C, Duval X, Mahida B, Hoen B, Goehringer F, Selton-Suty C, Chevalier E, Roch V, Lamiral Z, Bourdon A, Piriou N, Pallardy A, Morel O, Rouzet F, Marie PY; AEPEI-TEPvENDO Study Group. Hypermetabolism of the spleen or bone marrow is an additional albeit indirect sign of infective endocarditis at FDG-PET. J Nucl Cardiol. 2021 Dec;28(6):2533-2542. doi: 10.1007/s12350-020-02050-2. Epub 2020 Feb 10.
- Individual participant dataSharing planned: Undecided
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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.
Xavier Duval, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18-FDG PET/CT scan in people with Infective Endocarditis, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 7 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 8 Aug 2025. 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?
Proportion of patients with a change in IE therapeutic plan (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02287792, which also lists 3 linked publications.
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 8 Aug 2025.