NCT03429387

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

Early Diagnosis and Treatment of Infections in Patients With Haematologic Malignancies: Examining Novel Diagnostics Including Bacterial and Fungal Multiplex PCR and FDG-PET Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Haematopoietic Stem Cell Transplant, Autologous
• Haematopoietic Stem Cell Transplant, Allogeneic
• Febrile Neutropenia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FDG-PET/CT	FDG-PET performed with low dose CT
DIAGNOSTIC_TEST	Conventional CT	HRCT and CT of sinuses +/- other regions as per clinician's discretion

Timeline

• Start date: 2018-01-08
• Primary completion: 2020-08-01
• Completion: 2021-01-23
• First posted: 2018-02-12
• Last updated: 2022-05-17

Locations

2 sites across 1 country: Australia