PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia (PIPPIN)

Peter MacCallum Cancer Centre, Australia

Status: Completed

Conditions: Febrile Neutropenia; Haematopoietic Stem Cell Transplant, Allogeneic; Haematopoietic Stem Cell Transplant, Autologous; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Diagnostic Test: FDG-PET/CT; Diagnostic Test: Conventional CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03429387

17/98

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

FDG-PET/CT arm

Experimental group

Description:

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.

Treatment:

Diagnostic Test: FDG-PET/CT

Conventional CT arm

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Conventional CT