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

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ClinicalTrials.gov Identifier: NCT03429387
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
Melbourne Health
Westmead Hospital
Victorian Infectious Diseases Reference Laboratory
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Haematopoietic Stem Cell Transplant, Autologous Haematopoietic Stem Cell Transplant, Allogeneic Febrile Neutropenia Diagnostic Test: FDG-PET/CT Diagnostic Test: Conventional CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either the PET/CT arm or the conventional CT arm
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Diagnosis and Treatment of Infections in Patients With Haematologic Malignancies: Examining Novel Diagnostics Including Bacterial and Fungal Multiplex PCR and FDG-PET Imaging
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429387


Contacts
Contact: Abby Douglas, MBBS 61 3 8559 6136 abby.douglas@petermac.org
Contact: Monica Slavin, MBBS, MD 61 3 8559 7994 monica.slavin@petermac.org

Locations
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Abby P Douglas, MBBS    61 3 8559 6136    abby.douglas@petermac.org   
Principal Investigator: Abby P Douglas, MBBS         
Melbourne Health Recruiting
Parkville, Victoria, Australia, 3052
Contact: Monica A Slavin, MD    61 3 9342 7212    monica.slavin@mh.org.au   
Principal Investigator: Monica A Slavin, MD         
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Melbourne Health
Westmead Hospital
Victorian Infectious Diseases Reference Laboratory
Investigators
Principal Investigator: Monica Slavin, MBBS, MD Peter MacCallum Cancer Centre, Australia

Responsible Party: Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT03429387     History of Changes
Other Study ID Numbers: 17/98
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter MacCallum Cancer Centre, Australia:
Diagnosis

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Neutropenia
Fever
Febrile Neutropenia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms