PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
PIPPIN
Early Diagnosis and Treatment of Infections in Patients With Haematologic Malignancies: Examining Novel Diagnostics Including Bacterial and Fungal Multiplex PCR and FDG-PET Imaging
1 other identifier
interventional
147
1 country
2
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2017
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2021
CompletedMay 17, 2022
May 1, 2022
2.6 years
December 5, 2017
May 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in management following randomized scan
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 Outcomes (6)
Proportion of participants with a cause of neutropenic fever
By hospital discharge, an average of 4 weeks
Hospital length of stay
By hospital discharge, an average of 4 weeks
Costs of hospital care
By hospital discharge, an average of 4 weeks
Proportion admitted to intensive care
By hospital discharge, an average of 4 weeks
In hospital mortality
By hospital discharge, an average of 4 weeks
- +1 more secondary outcomes
Study Arms (2)
FDG-PET/CT arm
EXPERIMENTALParticipants 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.
Conventional CT arm
ACTIVE COMPARATORParticipants 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.
Interventions
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current actively diagnosed infection prior to transplant or chemotherapy
- Allergy to intravenous contrast for CT imaging
- eGFR \<30
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter MacCallum Cancer Centre, Australialead
- Melbourne Healthcollaborator
- Westmead Hospitalcollaborator
- Victorian Infectious Diseases Reference Laboratorycollaborator
Study Sites (2)
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Melbourne Health
Parkville, Victoria, 3052, Australia
Related Publications (2)
Tew M, Douglas AP, Szer J, Bajel A, Harrison SJ, Tio SY, Worth LJ, Hicks RJ, Ritchie D, Slavin MA, Thursky KA, Dalziel K. Evaluating the cost-effectiveness of [18F]FDG-PET/CT for investigation of persistent or recurrent neutropenic fever in high-risk haematology patients. Cancer Imaging. 2023 Dec 15;23(1):119. doi: 10.1186/s40644-023-00647-7.
PMID: 38102639DERIVEDDouglas 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.
PMID: 35777413DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica Slavin, MBBS, MD
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2017
First Posted
February 12, 2018
Study Start
January 8, 2018
Primary Completion
August 1, 2020
Study Completion
January 23, 2021
Last Updated
May 17, 2022
Record last verified: 2022-05