Clinical trial NCT03429387: PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Haematopoietic Stem Cell Transplant, Autologous
Haematopoietic Stem Cell Transplant, Allogeneic
Febrile Neutropenia
Keywords: Diagnosis
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
Collaborators: name: Melbourne Health
name: Westmead Hospital
name: Victorian Infectious Diseases Reference Laboratory
First posted: 2018-02-12
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the PET/CT arm or the conventional CT arm
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in management following randomized scan
timeFrame: Within 48 hours of scan result
Secondary outcomes:
measure: Proportion of participants with a cause of neutropenic fever
timeFrame: By hospital discharge, an average of 4 weeks
measure: Hospital length of stay
timeFrame: By hospital discharge, an average of 4 weeks
measure: Costs of hospital care
timeFrame: By hospital discharge, an average of 4 weeks
measure: Proportion admitted to intensive care
timeFrame: By hospital discharge, an average of 4 weeks
measure: In hospital mortality
timeFrame: By hospital discharge, an average of 4 weeks
measure: 6 month mortality
timeFrame: 6 months from study entry
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Parkville
country: Australia
facility: Melbourne Health
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Monica Slavin, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.