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Completed

NCT Number: NCT03419221

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Gui de Chauliac

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions

Procedure

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).

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

Other

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

Primary outcomes

  1. Presence of at least one DFI following the drawing of the first blood positive culture.

    Time frame: day 14

    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 outcomes

  1. PET/CT Evaluation :Frequency of SA-DFI

    Time frame: day 14

    Frequency of SA-DFI according to the investigator

  2. PET/CT Evaluation :Time to detection

    Time frame: day 14

    Time to detection of DFI

  3. Duration of Antibiotic treatment

    Time frame: 3 months

    Duration of antibiotic treatment

  4. Duration of Antibiotic treatment

    Time frame: 6 months

    Duration of antibiotic treatment

  5. frequency of Diagnostic procedures

    Time frame: 3 months

    frequency of procedures performed to treat SA-DFIs

  6. frequency of Diagnostic procedures

    Time frame: 6 months

    frequency of procedures performed to treat SA-DFIs

  7. Recurrences of S. aureus infection

    Time frame: 3 months

    Frequency of recurrences

  8. Recurrences of S. aureus infection

    Time frame: 6 months

    Frequency of recurrences

  9. Survival

    Time frame: 3 months

    Survival

  10. Survival

    Time frame: 6 months

    Survival

  11. Evaluation of the cost-effectiveness of strategies

    Time frame: 3 months

    Cost-effectiveness of strategies

  12. Evaluation of the cost-effectiveness of strategies

    Time frame: 6 months

    Cost-effectiveness of strategies

  13. Diagnostic procedures :Detection of endocardial hyperfixation

    Time frame: 3 months

    Detection of endocardial hyperfixation at PET/CT in arm A

  14. Diagnostic procedures :Detection of endocardial hyperfixation

    Time frame: 6 months

    Detection of endocardial hyperfixation at PET/CT in arm A

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection. An Open-comparative Randomized Trial

Acronym: TEPSTAR

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2018
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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