PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
- Conditions
- Febrile NeutropeniaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaHaematopoietic Stem Cell Transplant, AutologousHaematopoietic Stem Cell Transplant, Allogeneic
- Interventions
- Diagnostic Test: Conventional CTDiagnostic Test: FDG-PET/CT
- Registration Number
- NCT03429387
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- 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
- Current actively diagnosed infection prior to transplant or chemotherapy
- Allergy to intravenous contrast for CT imaging
- eGFR <30
- Pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional CT arm Conventional CT Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have a conventional CT (HRCT chest and sinuses +/- other regions as per clinician's discretion) performed to look for source of fever. FDG-PET/CT arm FDG-PET/CT Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have an FDG-PET/CT performed to look for source of fever.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
6 month mortality 6 months from study entry The proportion of patients per arm who have passed away 6 months post study entry
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
Trial Locations
- Locations (2)
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Melbourne Health
🇦🇺Parkville, Victoria, Australia