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

NCT02476487 | Completed

• 1 other identifier: 0377-14CTIL
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Management changes triggered by PET CT (percentage of management changes triggered by PET CT will be documented per patient group)

  1 year

Study Arms (1)

FDG PET CT

EXPERIMENTAL

FDG PET CT

Procedure: FDG PET CT

Interventions

FDG PET CT PROCEDURE

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.

FDG PET CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \>18y old with SAB, defined as at least one positive blood culture and at least two of the criteria of Systemic Inflammatory Response Syndrome (SIRS) (33):
• a temperature of more than 38°C or less than 36°C;
• an elevated heart rate greater than 90beats per minute;
• tachypnea, manifested by a respiratory rate greater than 20 breaths per minute or hyperventilation, as indicated by a partial pressure of arterial carbon dioxide of less than 32 mmHg;
• an alteration in the white blood cell count, such as a count greater than 12,000/cu mm, a count less than 4,000/cu mm; or the presence of more than 10% immature neutrophils.
• Patients with polymicrobial bacteremia will be included, but we will mandate growth of S. aureus in at least two blood culture bottles.

You may not qualify if:

• Pregnancy
• Infective endocarditis
• Patients with background survival expectation of less than 1 week.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Study Officials

• Mical Paul, MD

  Head of Infectious Diseases Unit, Rambam Health Care Campus, Haifa, Israel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 19, 2015
• Study Start: August 1, 2015
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)