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OpenTrials
Completed

NCT Number: NCT03429387

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Agranulocytosis Cytopenia Disease Febrile Neutropenia Haematopoietic Stem Cell Transplant, Allogeneic Haematopoietic Stem Cell Transplant, Autologous Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG-PET/CT

Diagnostic Test

FDG-PET performed with low dose CT

Other names: PET/CT

Conventional CT

Diagnostic Test

HRCT and CT of sinuses +/- other regions as per clinician's discretion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Collaborators

  • Melbourne Health
  • Victorian Infectious Diseases Reference Laboratory
  • Westmead Hospital

Registry information

Official study 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

Acronym: PIPPIN

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 12, 2018
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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