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Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection (TEPSTAR)

Primary Purpose

Staphylococcus Aureus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions
Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Staphylococcus Aureus focused on measuring Staphylococcus aureus, bloodstream infection, deep foci of infection, 18 FDG PET/CT, antibiotics

Eligibility Criteria

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

Inclusion Criteria:

  • - Aged over 18 years
  • Signed informed consent form
  • Subjects must be able to attend all scheduled visits and to comply with all trial procedures
  • Subjects must be covered by public health insurance
  • Hospitalized in one of the 10 participating centres
  • At least one peripheral blood culture isolating S. aureus
  • Absence of diagnosis of IE according to at least a transthoracic cardiac echography; cardiac echography will be performed via transesophageal procedure if the VIRSTA score is 3 or higher (see Appendix) or if transthoracic echography is not normal.

Exclusion Criteria:

  • - Any reason that may compromise compliance with the visit plan
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Deprived of liberty subjects (by judicial or administrative decision)
  • Adult under guardianshipCatheter-related SAB with resolution of symptoms of infection within 24 hours of ablation of catheter
  • Pregnancy or lactation
  • Isolation of S. aureus only in blood cultures drawn from a catheter or another implanted device
  • Catheter-related SAB with resolution of symptoms of infection within 24 hours of ablation of catheter
  • Uncontrolled septic shock and other instability contra-indicating the performance of PET/CT
  • Previous performance of PET/CT for the present episode of SAB
  • Indication to PET/CT for another reason (eg. neoplasm, infection of vascular graft…)
  • Contra-indication to PET/CT
  • Contraindication to Fluorodeoxyglucose : hypersensitivity to the active substance or to any of the excipients
  • Participation to another study unless specific authorization of the steering committee

Sites / Locations

  • Chu Gui de ChauliacRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A: Patients with PET/CT performs at day 14 after the drawing

B : Patients' routine care with performance of explorations

Arm Description

Arm A: Patients with PET/CT performs at day 14 after the drawing of the first blood culture

Arm B : Patients' routine care with performance of explorations based on anamnesis and clinical symptoms

Outcomes

Primary Outcome Measures

Presence of at least one DFI following the drawing of the first blood positive culture.
SA-DFI will be defined as the presence of at least one of the following criteria adapted form the criteria proposed by EMA for evaluation of antibiotics (EMA): Deep collection without any other explanation than S. aureus infection Osteomyelitis or arthritis without any other explanation than S. aureus infection; in case of presence of material (osteosynthesis or prosthetic joint) the presence of clinical symptoms or bacteriological confirmation will be required because the specificity of imaging including PET/CT is low Isolation of S. aureus in a sterile site other than blood, urine or catheter (eg: pleura, cerebrospinal fluid, bone, synovial fluid, muscle…)

Secondary Outcome Measures

PET/CT Evaluation :Frequency of SA-DFI
Frequency of SA-DFI according to the investigator
PET/CT Evaluation :Time to detection
Time to detection of DFI
Duration of Antibiotic treatment
Duration of antibiotic treatment
Duration of Antibiotic treatment
Duration of antibiotic treatment
frequency of Diagnostic procedures
frequency of procedures performed to treat SA-DFIs
frequency of Diagnostic procedures
frequency of procedures performed to treat SA-DFIs
Recurrences of S. aureus infection
Frequency of recurrences
Recurrences of S. aureus infection
Frequency of recurrences
Survival
Survival
Survival
Survival
Evaluation of the cost-effectiveness of strategies
Cost-effectiveness of strategies
Evaluation of the cost-effectiveness of strategies
Cost-effectiveness of strategies
Diagnostic procedures :Detection of endocardial hyperfixation
Detection of endocardial hyperfixation at PET/CT in arm A
Diagnostic procedures :Detection of endocardial hyperfixation
Detection of endocardial hyperfixation at PET/CT in arm A

Full Information

First Posted
November 8, 2017
Last Updated
December 20, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03419221
Brief Title
Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection
Acronym
TEPSTAR
Official Title
Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection. An Open-comparative Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
July 29, 2023 (Anticipated)
Study Completion Date
January 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
S. aureus bloodstream infection (SAB) is a severe disease associated with a 30% case-fatality rate at 12 weeks. Severity of this disease is related to the high prevalence of staphylococcal Deep Foci of Infection (SA-DFI), which require prolonged duration of antimicrobial therapy and specific treatment. Timely diagnosis and management of SA-DFI is associated with an improvement of prognosis during SAB. 18 FDG PET/CT (PET/CT) is a useful tool in the diagnosis of infectious foci during bacterial infections. An ecological study performed in the Netherlands has shown that use of PET/CT in patients with Gram positive cocci bloodstream infection was associated with an increase of detection of DFI and a decrease of recurrences and mortality compared to historical controls. The investigators hypothesize that SAB poor prognosis is in part related to the lack of diagnosis of all infectious foci and consequently to a suboptimal treatment.
Detailed Description
Subjects will be recruited in medical wards of the 10 participating hospitals. Each included patient will be managed according to clinical expertise of investigators who all are experts in the field of infectious diseases. Consensual guidelines for antimicrobial therapy of patients enrolled in the study will be written before the enrolment of the first patient by the steering committee composed of all co-investigators These guidelines will specify the nature of empiric therapy as well as adapted antibiotic therapy for each specific DFI for methicillin-sensitive as well as for methicillin resistant S. aureus. Experimental group: arm A All patients enrolled in arm A will have a PET/CT after enrolment and not later than day 14 after the drawing of first positive blood culture. Control group: arm B Patients enrolled in arm B will not have PET/CT before day 14. Other imaging studies will be guided by anamnesis and clinical symptoms and performed according to guidelines written consensually before the enrolment of the first patient by the steering committee

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus
Keywords
Staphylococcus aureus, bloodstream infection, deep foci of infection, 18 FDG PET/CT, antibiotics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Patients with PET/CT performs at day 14 after the drawing
Arm Type
Active Comparator
Arm Description
Arm A: Patients with PET/CT performs at day 14 after the drawing of the first blood culture
Arm Title
B : Patients' routine care with performance of explorations
Arm Type
Placebo Comparator
Arm Description
Arm B : Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
Intervention Type
Procedure
Intervention Name(s)
PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions
Intervention Description
Open-label randomized controlled superiority trial in patients with SAB without infective endocarditis at the time of inclusion comparing whole-body PET/CT in arm A and routine care with performance of imaging studies according to anamnesis and clinical symptoms in arm B. To demonstrate that PET/CT is associated with a 20% higher frequency of detection of DFI during SAB, the inclusion of 145 patients in each arm is required. Randomization will be stratified on centre and SAB setting of acquisition (healthcare vs community).
Intervention Type
Other
Intervention Name(s)
Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
Intervention Description
Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
Primary Outcome Measure Information:
Title
Presence of at least one DFI following the drawing of the first blood positive culture.
Description
SA-DFI will be defined as the presence of at least one of the following criteria adapted form the criteria proposed by EMA for evaluation of antibiotics (EMA): Deep collection without any other explanation than S. aureus infection Osteomyelitis or arthritis without any other explanation than S. aureus infection; in case of presence of material (osteosynthesis or prosthetic joint) the presence of clinical symptoms or bacteriological confirmation will be required because the specificity of imaging including PET/CT is low Isolation of S. aureus in a sterile site other than blood, urine or catheter (eg: pleura, cerebrospinal fluid, bone, synovial fluid, muscle…)
Time Frame
day 14
Secondary Outcome Measure Information:
Title
PET/CT Evaluation :Frequency of SA-DFI
Description
Frequency of SA-DFI according to the investigator
Time Frame
day 14
Title
PET/CT Evaluation :Time to detection
Description
Time to detection of DFI
Time Frame
day 14
Title
Duration of Antibiotic treatment
Description
Duration of antibiotic treatment
Time Frame
3 months
Title
Duration of Antibiotic treatment
Description
Duration of antibiotic treatment
Time Frame
6 months
Title
frequency of Diagnostic procedures
Description
frequency of procedures performed to treat SA-DFIs
Time Frame
3 months
Title
frequency of Diagnostic procedures
Description
frequency of procedures performed to treat SA-DFIs
Time Frame
6 months
Title
Recurrences of S. aureus infection
Description
Frequency of recurrences
Time Frame
3 months
Title
Recurrences of S. aureus infection
Description
Frequency of recurrences
Time Frame
6 months
Title
Survival
Description
Survival
Time Frame
3 months
Title
Survival
Description
Survival
Time Frame
6 months
Title
Evaluation of the cost-effectiveness of strategies
Description
Cost-effectiveness of strategies
Time Frame
3 months
Title
Evaluation of the cost-effectiveness of strategies
Description
Cost-effectiveness of strategies
Time Frame
6 months
Title
Diagnostic procedures :Detection of endocardial hyperfixation
Description
Detection of endocardial hyperfixation at PET/CT in arm A
Time Frame
3 months
Title
Diagnostic procedures :Detection of endocardial hyperfixation
Description
Detection of endocardial hyperfixation at PET/CT in arm A
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Aged over 18 years Signed informed consent form Subjects must be able to attend all scheduled visits and to comply with all trial procedures Subjects must be covered by public health insurance Hospitalized in one of the 10 participating centres At least one peripheral blood culture isolating S. aureus Absence of diagnosis of IE according to at least a transthoracic cardiac echography; cardiac echography will be performed via transesophageal procedure if the VIRSTA score is 3 or higher (see Appendix) or if transthoracic echography is not normal. Exclusion Criteria: - Any reason that may compromise compliance with the visit plan Planned longer stay outside the region that prevents compliance with the visit plan Deprived of liberty subjects (by judicial or administrative decision) Adult under guardianshipCatheter-related SAB with resolution of symptoms of infection within 24 hours of ablation of catheter Pregnancy or lactation Isolation of S. aureus only in blood cultures drawn from a catheter or another implanted device Catheter-related SAB with resolution of symptoms of infection within 24 hours of ablation of catheter Uncontrolled septic shock and other instability contra-indicating the performance of PET/CT Previous performance of PET/CT for the present episode of SAB Indication to PET/CT for another reason (eg. neoplasm, infection of vascular graft…) Contra-indication to PET/CT Contraindication to Fluorodeoxyglucose : hypersensitivity to the active substance or to any of the excipients Participation to another study unless specific authorization of the steering committee
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quam Ed AQUEREBURU, CRA
Phone
0467332127
Email
qe-aquereburu@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillemette TACONNET DECKER
Phone
0467335573
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent LE MOING, Professor
Organizational Affiliation
Infectious Diseases department of CHU-Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LE MOING VINCENT

12. IPD Sharing Statement

Learn more about this trial

Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection

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