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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Patients with PET/CT performs at day 14 after the drawing | Active Comparator | Arm A: Patients with PET/CT performs at day 14 after the drawing of the first blood culture |
|
| B : Patients' routine care with performance of explorations | Placebo Comparator | Arm B : Patients' routine care with performance of explorations based on anamnesis and clinical symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| PET/CT Evaluation :Frequency of SA-DFI | Frequency of SA-DFI according to the investigator | day 14 |
| PET/CT Evaluation :Time to detection | Time to detection of DFI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent LE MOING, Professor | Infectious Diseases department of CHU-Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Gui de Chauliac | Montpellier | 34295 | France |
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|
| 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 |
|
| day 14 |
| Duration of Antibiotic treatment | Duration of antibiotic treatment | 3 months |
| Duration of Antibiotic treatment | Duration of antibiotic treatment | 6 months |
| frequency of Diagnostic procedures | frequency of procedures performed to treat SA-DFIs | 3 months |
| frequency of Diagnostic procedures | frequency of procedures performed to treat SA-DFIs | 6 months |
| Recurrences of S. aureus infection | Frequency of recurrences | 3 months |
| Recurrences of S. aureus infection | Frequency of recurrences | 6 months |
| Survival | Survival | 3 months |
| Survival | Survival | 6 months |
| Evaluation of the cost-effectiveness of strategies | Cost-effectiveness of strategies | 3 months |
| Evaluation of the cost-effectiveness of strategies | Cost-effectiveness of strategies | 6 months |
| Diagnostic procedures :Detection of endocardial hyperfixation | Detection of endocardial hyperfixation at PET/CT in arm A | 3 months |
| Diagnostic procedures :Detection of endocardial hyperfixation | Detection of endocardial hyperfixation at PET/CT in arm A | 6 months |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
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