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

Acute Myeloid Leukemia Clinical Trial

— PIPPIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429387
• Other study ID #: 17/98
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: January 23, 2021

Study information

• Verified date: May 2022
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: January 23, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Febrile Neutropenia
• Fever
• Haematopoietic Stem Cell Transplant, Allogeneic
• Haematopoietic Stem Cell Transplant, Autologous
• Hyperthermia
• Leukemia
• Neutropenia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Diagnostic Test:
• FDG-PET/CT
FDG-PET performed with low dose CT
• Conventional CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Melbourne Health	Parkville	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia	Melbourne Health, Victorian Infectious Diseases Reference Laboratory, Westmead Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	By hospital discharge, an average of 4 weeks
Secondary	Hospital length of stay	The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred	By hospital discharge, an average of 4 weeks
Secondary	Costs of hospital care	The overall cost of the inpatient stay for the episode in which neutropenic fever occurred	By hospital discharge, an average of 4 weeks
Secondary	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	By hospital discharge, an average of 4 weeks
Secondary	In hospital mortality	The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred	By hospital discharge, an average of 4 weeks
Secondary	6 month mortality	The proportion of patients per arm who have passed away 6 months post study entry	6 months from study entry