NCT03419221

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Staphylococcus Aureus

Interventions

Type	Name	Description
PROCEDURE	PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions	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).
OTHER	Patients' routine care with performance of explorations based on anamnesis and clinical symptoms	Patients' routine care with performance of explorations based on anamnesis and clinical symptoms

Timeline

• Start date: 2018-01-29
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2018-02-01
• Last updated: 2025-04-18

Locations

1 site across 1 country: France