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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03429387
Registration number
NCT03429387
Ethics application status
Date submitted
5/12/2017
Date registered
12/02/2018
Titles & IDs
Public title
PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
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Scientific 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
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Secondary ID [1]
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17/98
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Universal Trial Number (UTN)
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Trial acronym
PIPPIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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0
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Acute Lymphoblastic Leukemia
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0
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Haematopoietic Stem Cell Transplant, Autologous
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0
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Haematopoietic Stem Cell Transplant, Allogeneic
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0
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Febrile Neutropenia
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0
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Condition category
Condition code
Cancer
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0
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Blood
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0
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0
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Other blood disorders
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Injuries and Accidents
0
0
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - FDG-PET/CT
Diagnosis / Prognosis - Conventional CT
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.
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.
Diagnosis / Prognosis: FDG-PET/CT
FDG-PET performed with low dose CT
Diagnosis / Prognosis: Conventional CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in management following randomized scan
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Assessment method [1]
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Defined as:
* referral for targeted sampling, referral for surgery
* change in antimicrobial therapy
* removal of a central line
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Timepoint [1]
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Within 48 hours of scan result
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Secondary outcome [1]
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Proportion of participants with a cause of neutropenic fever
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Assessment method [1]
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The proportion of participants in each arm where there is a confirmed cause of neutropenic fever
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Timepoint [1]
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By hospital discharge, an average of 4 weeks
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Secondary outcome [2]
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Hospital length of stay
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Assessment method [2]
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The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
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Timepoint [2]
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By hospital discharge, an average of 4 weeks
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Secondary outcome [3]
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Costs of hospital care
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Assessment method [3]
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The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
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Timepoint [3]
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By hospital discharge, an average of 4 weeks
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Secondary outcome [4]
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Proportion admitted to intensive care
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Assessment method [4]
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The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred
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Timepoint [4]
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By hospital discharge, an average of 4 weeks
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Secondary outcome [5]
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In hospital mortality
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Assessment method [5]
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The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred
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Timepoint [5]
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By hospital discharge, an average of 4 weeks
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Secondary outcome [6]
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6 month mortality
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Assessment method [6]
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The proportion of patients per arm who have passed away 6 months post study entry
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Timepoint [6]
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6 months from study entry
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Current actively diagnosed infection prior to transplant or chemotherapy
* Allergy to intravenous contrast for CT imaging
* eGFR <30
* Pregnant
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/01/2021
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Sample size
Target
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Accrual to date
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Final
147
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
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Melbourne Health - Parkville
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melbourne Health
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Address [1]
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0
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Westmead Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Victorian Infectious Diseases Reference Laboratory
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03429387
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Trial related presentations / publications
Douglas A, Thursky K, Spelman T, Szer J, Bajel A, Harrison S, Tio SY, Bupha-Intr O, Tew M, Worth L, Teh B, Chee L, Ng A, Carney D, Khot A, Haeusler G, Yong M, Trubiano J, Chen S, Hicks R, Ritchie D, Slavin M. [18F]FDG-PET-CT compared with CT for persistent or recurrent neutropenic fever in high-risk patients (PIPPIN): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Haematol. 2022 Aug;9(8):e573-e584. doi: 10.1016/S2352-3026(22)00166-1. Epub 2022 Jun 28.
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Public notes
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Contacts
Principal investigator
Name
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Monica Slavin, MBBS, MD
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03429387