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

NCT03429387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2022-05-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Melbourne Health

    collaborator OTHER

  • Westmead Hospital

    collaborator UNKNOWN

  • Victorian Infectious Diseases Reference Laboratory

    collaborator UNKNOWN

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Monica Slavin, MBBS, MD · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2020-08-01
Completion
2021-01-23

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429387 on ClinicalTrials.gov