Acute Myeloid LeukemiaPIPPINNCT03429387
PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
A study testing FDG-PET/CT and Conventional CT in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Peter MacCallum Cancer Centre, Australia at 2 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Haematopoietic Stem Cell Transplant, Autologous
- What is being tested?
- FDG-PET/CT and Conventional CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesAustralia
- Study dates
- 8 Jan 2018to 23 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current actively diagnosed infection prior to transplant or chemotherapy
- Allergy to intravenous contrast for CT imaging
- eGFR <30
- Pregnant
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Melbourne Health
Parkville, Victoria, 3052
About this study
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
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.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Haematopoietic Stem Cell Transplant, Autologous, Haematopoietic Stem Cell Transplant, Allogeneic, Febrile Neutropenia
- Being tested
- FDG-PET/CT, Conventional CT
- Keywords
- Diagnosis
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Febrile Neutropenia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET/CTDiagnostic test
Also called PET/CT
FDG-PET performed with low dose CT
Conventional CTDiagnostic test
HRCT and CT of sinuses +/- other regions as per clinician's discretion
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET/CT arm | Experimental | 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. Receives: Diagnostic Test: FDG-PET/CT |
| Conventional CT arm | Active comparator | 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. Receives: Diagnostic Test: Conventional CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in management following randomized scan
Defined as:
- referral for targeted sampling, referral for surgery
- change in antimicrobial therapy
- removal of a central line
Measured: Within 48 hours of scan result
Secondary outcomes (6)
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
Measured: By hospital discharge, an average of 4 weeks
Hospital length of stay
The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
Measured: By hospital discharge, an average of 4 weeks
Costs of hospital care
The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
Measured: By hospital discharge, an average of 4 weeks
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
Measured: By hospital discharge, an average of 4 weeks
In hospital mortality
The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred
Measured: By hospital discharge, an average of 4 weeks
6 month mortality
The proportion of patients per arm who have passed away 6 months post study entry
Measured: 6 months from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start8 Jan 2018
- Primary completion1 Aug 2020
- Study completion23 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the PET/CT arm or the conventional CT arm
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health, Westmead Hospital, Victorian Infectious Diseases Reference Laboratory
- Responsible party
- Sponsor
- Investigators
- Monica Slavin, MBBS, MD, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429387
- Sponsor's protocol ID
- 17/98
- Acronym
- PIPPIN
- Status last verified
- May 2022
- First submitted
- 5 Dec 2017
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38102639Douglas 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.
PubMed 35777413
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03429387
- Acronym / sponsor ID
- PIPPIN / 17/98
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Haematopoietic Stem Cell Transplant, Autologous, Haematopoietic Stem Cell Transplant, Allogeneic, Febrile Neutropenia
- Keywords
- Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- Melbourne Health, Westmead Hospital, Victorian Infectious Diseases Reference Laboratory
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the PET/CT arm or the conventional CT arm
| Arm | Type | Receives |
|---|---|---|
| FDG-PET/CT arm | Experimental | Diagnostic Test: FDG-PET/CTParticipants 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 comparator | Diagnostic Test: Conventional CTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Current actively diagnosed infection prior to transplant or chemotherapy
- Allergy to intravenous contrast for CT imaging
- eGFR <30
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PET/CTAlso: PET/CTFDG-PET performed with low dose CT | Diagnostic test | FDG-PET/CT arm |
| Conventional CTHRCT and CT of sinuses +/- other regions as per clinician's discretion | Diagnostic test | Conventional CT arm |
Primary outcome
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
6 secondary outcomes
Proportion of participants with a cause of neutropenic fever
Time frame: By hospital discharge, an average of 4 weeks
Hospital length of stay
Time frame: By hospital discharge, an average of 4 weeks
Costs of hospital care
Time frame: By hospital discharge, an average of 4 weeks
Proportion admitted to intensive care
Time frame: By hospital discharge, an average of 4 weeks
In hospital mortality
Time frame: By hospital discharge, an average of 4 weeks
6 month mortality
Time frame: 6 months from study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 38102639Tew 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.
- Derived from this study: PubMed 35777413Douglas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Slavin, MBBS, MD principal investigator
Peter MacCallum Cancer Centre, Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG-PET/CT and Conventional CT in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Peter MacCallum Cancer Centre, Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in management following randomized scan (time frame: Within 48 hours of scan result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.