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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03429387




Registration number
NCT03429387
Ethics application status
Date submitted
5/12/2017
Date registered
12/02/2018
Date last updated
9/09/2020

Titles & IDs
Public title
PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
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
Secondary ID [1] 0 0
17/98
Universal Trial Number (UTN)
Trial acronym
PIPPIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Acute Lymphoblastic Leukemia 0 0
Haematopoietic Stem Cell Transplant, Autologous 0 0
Haematopoietic Stem Cell Transplant, Allogeneic 0 0
Febrile Neutropenia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in management following randomized scan - Defined as:
referral for targeted sampling, referral for surgery
change in antimicrobial therapy
removal of a central line
Timepoint [1] 0 0
Within 48 hours of scan result
Secondary outcome [1] 0 0
Proportion of participants with a cause of neutropenic fever - The proportion of participants in each arm where there is a confirmed cause of neutropenic fever
Timepoint [1] 0 0
By hospital discharge, an average of 4 weeks
Secondary outcome [2] 0 0
Hospital length of stay - The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
Timepoint [2] 0 0
By hospital discharge, an average of 4 weeks
Secondary outcome [3] 0 0
Costs of hospital care - The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
Timepoint [3] 0 0
By hospital discharge, an average of 4 weeks
Secondary outcome [4] 0 0
Proportion admitted to intensive care - The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred
Timepoint [4] 0 0
By hospital discharge, an average of 4 weeks
Secondary outcome [5] 0 0
In hospital mortality - The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred
Timepoint [5] 0 0
By hospital discharge, an average of 4 weeks
Secondary outcome [6] 0 0
6 month mortality - The proportion of patients per arm who have passed away 6 months post study entry
Timepoint [6] 0 0
6 months from study entry

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current actively diagnosed infection prior to transplant or chemotherapy

- Allergy to intravenous contrast for CT imaging

- eGFR <30

- Pregnant

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Melbourne Health - Parkville
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Westmead Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Victorian Infectious Diseases Reference Laboratory
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03429387
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Monica Slavin, MBBS, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications