Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02476487 |
| Other study ID # |
0377-14CTIL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2015 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Rambam Health Care Campus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives :
Since it has been shown that PET CT is a sensitive modality for detecting complications of
Gram-positive bacteremia, mainly S. aureus, we sought to examine a diagnostic algorithm of
SAB using PET CT. Specifically, we plan to examine:
1. In patients fulfilling current criteria for a short course of antibiotic treatment for
SAB, are there patients who should receive longer treatment due to the presence of
undetected foci of infection on PET CT?
2. In patients with risk factors mandating prolonged antibiotic treatment according to
current guidelines (without IE) and a negative PET CT, is treatment discontinuation
after two weeks of treatment safe?
3. For patients with primary bacteremia, does a PET CT improve outcome (relapses, length of
stay (LOS), survival)?
Study design:
A prospective, interventional, non-comparative cohort study
Setting and location:
Rambam Health Care Campus, a primary and tertiary 900-bed university-affiliated hospital.
Treatment algorithm:
All patients will be managed using a uniform diagnostic/ treatment algorithm, supervised by
an infectious disease consultant.
Patients will be classified into two groups (table 1):
Group 1- patients fulfilling criteria of complicated bacteremia Group 2- patients with
uncomplicated bacteremia PET CT will be performed on day 7-14 since the first positive blood
culture. If findings suggestive of infection will be demonstrated on FDG-PET imaging, the
treating clinician will consider these finding, in consultation with a PET-expert radiologist
and an infectious disease consultant. If an infection is considered likely, the clinician may
consider attempting to obtain a tissue specimen in order to confirm the suspicion.
1. Patients fulfilling current criteria for a short course 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 according to current
guidelines without IE: antibiotics will be stopped at 2 weeks if PET CT is normal.
Participant recruitment and data collection:
Patients will be identified through a daily report of S. aureus growth in blood cultures. The
researchers will apply inclusion and exclusion criteria on this preliminary cohort. All
patients fulfilling inclusion criteria and providing informed consent will be consecutively
enrolled. Patients will be followed up by clinical consultations until discharge.
Post-discharge patients will be followed-up until 1 year after end of treatment through
telephone interviews and through clinical consultations if re-admitted to our hospital.
Diagnostic test:
Imaging Protocols:
FDG-PET/CT will be performed 60-90 min after radiopharmaceutical injection from the skull to
the half thigh. Oral contrast will be given during the uptake time. Analysis of the PET/CT
images include:
1. Visual inspection to exclude misregistration between the PET and the CT components.
2. Visual inspection of images and semiquantitative evaluation by maximum standardized
uptake value (SUVmax) evaluation.
3. Localizing any focus of abnormal radioactivity accumulation indicating infection.
Analysis:
The percentage of management changes triggered by PET CT will be documented per patient
group. To refute the null hypothesis, i.e. no difference in patient management with or
without PET CT, we will define that the lower limit of the 95% confidence interval (CI) for
the percentage of management changes be >10%. Assuming a 15% rate of management changes, a
sample of 150 will achieve the required 95% CI. If the percentage will be 20%, we will need
only 60 patients. The number of patients to be included will depend on the percentage of
management changes and will be monitored every 10 patients. We will compare outcomes
documented in the study cohort to those reported in the literature.
