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18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis (TEPvENDO)

Primary Purpose

Infective Endocarditis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18-FDG PET/CT scan
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infective Endocarditis focused on measuring Infective endocarditis, 18-FDG PET/CT, Impact, Patient's management, Diagnostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects aged ≥ 18 years
  2. 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".
  3. Transthoracic or transesophageal ultrasound performed.
  4. A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
  5. Absence of cardiac surgery for the current IE episode
  6. Covered by the French health insurance system
  7. Having given and signed the written study informed consent to the study.

Exclusion Criteria:

  1. Patient having already had a 18-FDG PET/CT in the current episode
  2. Contraindication to perform a 18-FDG PET/CT
  3. Early prosthetic valve IE (cardiac surgery within last 2 months)
  4. Inability to understand the information form
  5. Pregnant or lactating woman.
  6. Cardiac surgery between inclusion and 18-FDG PET/CT
  7. Participation to any clinical trial including 18-FDG PET/CT

Sites / Locations

  • Bichat Claude Bernard Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18-FDG PET/CT scan

Arm Description

All patients will undergo a whole body PET/CT scan

Outcomes

Primary Outcome Measures

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…)

Secondary Outcome Measures

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
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
6-month mortality rate
number of dead patients 6 months after inclusion
Determinants of change in therapeutic plan as defined in primary outcome
Clinical and biological determinants of therapeutic changes
18-FDG PET/CT inter-reader reproducibility
questionnaire

Full Information

First Posted
October 31, 2014
Last Updated
July 24, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02287792
Brief Title
18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis
Acronym
TEPvENDO
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 17, 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis
Keywords
Infective endocarditis, 18-FDG PET/CT, Impact, Patient's management, Diagnostic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18-FDG PET/CT scan
Arm Type
Experimental
Arm Description
All patients will undergo a whole body PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
18-FDG PET/CT scan
Intervention Description
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
Primary Outcome Measure Information:
Title
Proportion of patients with a change in IE therapeutic plan
Description
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Proportion of patients with Duke-Li classification modifications
Description
Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification
Time Frame
6 months
Title
Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures
Description
1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE
Time Frame
6 months
Title
6-month mortality rate
Description
number of dead patients 6 months after inclusion
Time Frame
6 months
Title
Determinants of change in therapeutic plan as defined in primary outcome
Description
Clinical and biological determinants of therapeutic changes
Time Frame
6 months
Title
18-FDG PET/CT inter-reader reproducibility
Description
questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Duval, Professor
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32488236
Citation
Duval 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 Reference
derived

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18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis

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