Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Haematopoietic Stem Cell Transplant, Autologous, Haematopoietic Stem Cell Transplant, Allogeneic, Febrile Neutropenia
Conditions
Keywords
Diagnosis
Brief summary
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.
Interventions
DIAGNOSTIC_TESTFDG-PET/CT
FDG-PET performed with low dose CT
DIAGNOSTIC_TESTConventional CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Sponsors
Melbourne Health
Westmead Hospital
Victorian Infectious Diseases Reference Laboratory
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants will be randomized to either the PET/CT arm or the conventional CT arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* About to have an allogeneic haematopoietic stem cell transplant, OR * About to have an autologous haematopoietic stem cell transplant, OR * Commencing induction or consolidation chemotherapy with curative intent for acute myeloid or acute lymphoid leukaemia
Exclusion criteria
* Current actively diagnosed infection prior to transplant or chemotherapy * Allergy to intravenous contrast for CT imaging * eGFR \<30 * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in management following randomized scan | Within 48 hours of scan result | Defined as: * referral for targeted sampling, referral for surgery * change in antimicrobial therapy * removal of a central line |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | By hospital discharge, an average of 4 weeks | The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred |
| Costs of hospital care | By hospital discharge, an average of 4 weeks | The overall cost of the inpatient stay for the episode in which neutropenic fever occurred |
| Proportion of participants with a cause of neutropenic fever | By hospital discharge, an average of 4 weeks | The proportion of participants in each arm where there is a confirmed cause of neutropenic fever |
| In hospital mortality | By hospital discharge, an average of 4 weeks | The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred |
| 6 month mortality | 6 months from study entry | The proportion of patients per arm who have passed away 6 months post study entry |
| Proportion admitted to intensive care | By hospital discharge, an average of 4 weeks | The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred |
Countries
Australia
Outcome results
None listed