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

NCT03419221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2025-04-18

No results posted yet for this study

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.

Conditions

  • Staphylococcus Aureus

Interventions

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Vincent LE MOING, Professor · Infectious Diseases department of CHU-Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2025-03-20
Completion
2025-03-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03419221 on ClinicalTrials.gov