Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated. This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
147
FDG-PET performed with low dose CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Melbourne Health
Parkville, Victoria, Australia
Change in management following randomized scan
Defined as: * referral for targeted sampling, referral for surgery * change in antimicrobial therapy * removal of a central line
Time frame: Within 48 hours of scan result
Proportion of participants with a cause of neutropenic fever
The proportion of participants in each arm where there is a confirmed cause of neutropenic fever
Time frame: By hospital discharge, an average of 4 weeks
Hospital length of stay
The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
Costs of hospital care
The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
Proportion admitted to intensive care
The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
In hospital mortality
The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
6 month mortality
The proportion of patients per arm who have passed away 6 months post study entry
Time frame: 6 months from study entry
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