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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
291
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
Chu Gui de Chauliac
Montpellier, France
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…)
Time frame: day 14
PET/CT Evaluation :Frequency of SA-DFI
Frequency of SA-DFI according to the investigator
Time frame: day 14
PET/CT Evaluation :Time to detection
Time to detection of DFI
Time frame: day 14
Duration of Antibiotic treatment
Duration of antibiotic treatment
Time frame: 3 months
Duration of Antibiotic treatment
Duration of antibiotic treatment
Time frame: 6 months
frequency of Diagnostic procedures
frequency of procedures performed to treat SA-DFIs
Time frame: 3 months
frequency of Diagnostic procedures
frequency of procedures performed to treat SA-DFIs
Time frame: 6 months
Recurrences of S. aureus infection
Frequency of recurrences
Time frame: 3 months
Recurrences of S. aureus infection
Frequency of recurrences
Time frame: 6 months
Survival
Survival
Time frame: 3 months
Survival
Survival
Time frame: 6 months
Evaluation of the cost-effectiveness of strategies
Cost-effectiveness of strategies
Time frame: 3 months
Evaluation of the cost-effectiveness of strategies
Cost-effectiveness of strategies
Time frame: 6 months
Diagnostic procedures :Detection of endocardial hyperfixation
Detection of endocardial hyperfixation at PET/CT in arm A
Time frame: 3 months
Diagnostic procedures :Detection of endocardial hyperfixation
Detection of endocardial hyperfixation at PET/CT in arm A
Time frame: 6 months
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