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

Staphylococcus Aureus Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Infections
• Sepsis
• Staphylococcal Infections
• Staphylococcus Aureus

• NCT number: NCT03419221
• Study type: Interventional
• Source: University Hospital, Montpellier
• Contact: Quam Ed AQUEREBURU, CRA
• Phone: 0467332127
• Email: qe-aquereburu@chu-montpellier.fr
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2018
• Completion date: January 29, 2024