AzTrials
AzTrials

Staphylococcus AureusTEPSTARNCT03419221

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

A study testing PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions and Patients' routine care with performance of explorations based on anamnesis and clinical symptoms in people with Staphylococcus Aureus, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Staphylococcus Aureus
What is being tested?
PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions and Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
291 participants
Where
1 siteFrance
Study dates
29 Jan 2018to 20 Mar 2025
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

  • - 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.

Who cannot join

  • - 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu Gui de Chauliac

    Montpellier, 34295

Other trials in France

About this study

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

  1. 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.

Read the 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

Being tested
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
Keywords
Staphylococcus aureus, bloodstream infection, deep foci of infection, 18 FDG PET/CT, antibiotics
Medical subject headings
Staphylococcal Infections, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 symptomsOther

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

Study groups in NCT03419221
Study groupRoleWhat they receive
A: Patients with PET/CT performs at day 14 after the drawingActive comparatorArm A: Patients with PET/CT performs at day 14 after the drawing of the first blood culture
Receives: Procedure: PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions
B : Patients' routine care with performance of explorationsPlacebo comparatorArm B : Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
Receives: Other: Patients' routine care with performance of explorations based on anamnesis and clinical symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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…)

    Measured: day 14

Secondary outcomes (14)

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

    Frequency of SA-DFI according to the investigator

    Measured: day 14

  2. PET/CT Evaluation :Time to detection

    Time to detection of DFI

    Measured: day 14

  3. Duration of Antibiotic treatment

    Duration of antibiotic treatment

    Measured: 3 months

  4. Duration of Antibiotic treatment

    Duration of antibiotic treatment

    Measured: 6 months

  5. frequency of Diagnostic procedures

    frequency of procedures performed to treat SA-DFIs

    Measured: 3 months

  6. frequency of Diagnostic procedures

    frequency of procedures performed to treat SA-DFIs

    Measured: 6 months

  7. Recurrences of S. aureus infection

    Frequency of recurrences

    Measured: 3 months

  8. Recurrences of S. aureus infection

    Frequency of recurrences

    Measured: 6 months

  9. Survival

    Survival

    Measured: 3 months

  10. Survival

    Survival

    Measured: 6 months

  11. Evaluation of the cost-effectiveness of strategies

    Cost-effectiveness of strategies

    Measured: 3 months

  12. Evaluation of the cost-effectiveness of strategies

    Cost-effectiveness of strategies

    Measured: 6 months

  13. Diagnostic procedures :Detection of endocardial hyperfixation

    Detection of endocardial hyperfixation at PET/CT in arm A

    Measured: 3 months

  14. Diagnostic procedures :Detection of endocardial hyperfixation

    Detection of endocardial hyperfixation at PET/CT in arm A

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2018
  2. Study start29 Jan 2018
  3. Primary completion20 Mar 2025
  4. Study completion20 Mar 2025

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03419221
Sponsor's protocol ID
UF 9788
Acronym
TEPSTAR
Status last verified
Apr 2025
First submitted
8 Nov 2017
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions and Patients' routine care with performance of explorations based on anamnesis and clinical symptoms in people with Staphylococcus Aureus, run by University Hospital, Montpellier 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 13 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 18 Apr 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. Some participants in this study may receive a placebo. 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?

Presence of at least one DFI following the drawing of the first blood positive culture. (time frame: day 14). 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 NCT03419221.

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 18 Apr 2025.

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