The Benefit of FDG PET CT in the Treatment Algorithm of Staphylococcus Aureus Bacteremia

Summary

Background: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals, with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB, other than in cases of Infective endocarditis (IE), recommended by different guidelines relies on risk stratification for relapse of infection rather than definite diagnosis of septic foci that eventually determine the relapse rate. In recently published studies fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying metastatic infectious foci in Gram-positive bacteremia, including SAB.

Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE SAB compared to standard treatment recommendations on treatment duration and clinical outcomes.

Methods: A prospective interventional non-comparative cohort study conducted at Rambam Health Care Campus. Patients with SAB, defined as microbiologically and clinically, will undergo FDG PET CT 10-14 days following the first positive blood culture for diagnosis of septic extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks) versus long treatment (4-6 weeks) will be recommended for negative and positive PET CT tests, respectively. Patients will be followed-up for 1 year for relapse of infection and mortality.

We will document the sensitivity and specificity of PET CT for detection of complications among patients with SAB. We will examine the percentage of patients in whom the use of PET CT changed treatment duration compared to standard recommendations. We will compare also, the relapse rate and 1 year mortality rate with data from previous studies and local data. Assuming a 15% rate of management changes compared to consensus recommendations, a sample of 150 patients will achieve the required 95% CI.

Significance: Our trial will serve for improving decision making in patients with non-IE SAB, shortening treatment duration in unnecessary cases and decreasing relapse rate by giving prolonged appropriate treatment for metastatic infection not identified by standard management algorithms. PET CT is assuming an increasingly important role in infection diagnosis and management. The current study will be the first to examine the role of PET CT in directing management of patients with SAB.

Conditions

• Staphylococcus Aureus Bacteremia

Interventions

PROCEDURE

FDG PET CT

FDG-PET CT will be performed on day 7-14 since the first positive blood culture. 1. Patients fulfilling current criteria for a short course (2 weeks) of antibiotic treatment: treatment will be prolonged if PET CT demonstrates a focus of residual infection. 2\. Patients with risk factors mandating prolonged antibiotic treatment (4-6 weeks) according to current guidelines without IE: antibiotics will be stopped at 2 weeks if PET CT is normal.

Sponsors & Collaborators

• Rambam Health Care Campus

  lead OTHER

Principal Investigators

• Mical Paul, MD · Head of Infectious Diseases Unit, Rambam Health Care Campus, Haifa, Israel

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-01

Primary Completion

2020-12-30

Completion

2021-12-31

Countries

• Israel

Study Locations