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

May 15, 2022 updated by: Peter MacCallum Cancer Centre, Australia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
      • Parkville, Victoria, Australia, 3052
        • Melbourne Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FDG-PET/CT arm
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.
Diagnostic test: FDG-PET/CT
FDG-PET performed with low dose CT
Other Names:
  • PET/CT
ACTIVE_COMPARATOR: Conventional CT arm
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.
Diagnostic test: Conventional CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in management following randomized scan
Time Frame: Within 48 hours of scan result

Defined as:

  • referral for targeted sampling, referral for surgery
  • change in antimicrobial therapy
  • removal of a central line
Within 48 hours of scan result

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with a cause of neutropenic fever
Time Frame: By hospital discharge, an average of 4 weeks
The proportion of participants in each arm where there is a confirmed cause of neutropenic fever
By hospital discharge, an average of 4 weeks
Hospital length of stay
Time Frame: 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
By hospital discharge, an average of 4 weeks
Costs of hospital care
Time Frame: By hospital discharge, an average of 4 weeks
The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
By hospital discharge, an average of 4 weeks
Proportion admitted to intensive care
Time Frame: 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
By hospital discharge, an average of 4 weeks
In hospital mortality
Time Frame: 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
By hospital discharge, an average of 4 weeks
6 month mortality
Time Frame: 6 months from study entry
The proportion of patients per arm who have passed away 6 months post study entry
6 months from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter MacCallum Cancer Centre, Australia

Collaborators

Melbourne Health
Westmead Hospital
Victorian Infectious Diseases Reference Laboratory

Investigators

  • Principal Investigator: Monica Slavin, MBBS, MD, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2018

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

January 23, 2021

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

February 5, 2018

First Posted (ACTUAL)

February 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 15, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/98

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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