Clinical trial · Interventional
PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
Early Diagnosis and Treatment of Infections in Patients With Haematologic Malignancies: Examining Novel Diagnostics Including Bacterial and Fungal Multiplex PCR and FDG-PET Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Haematopoietic Stem Cell Transplant, Allogeneic | — | UNRESOLVED | — |
| Haematopoietic Stem Cell Transplant, Autologous | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional CT | Diagnostic Test | — | UNRESOLVED |
| FDG-PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FDG-PET/CT arm
- description
- 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.
- interventionNames
- Diagnostic Test: FDG-PET/CT
- type
- ACTIVE_COMPARATOR
- label
- Conventional CT arm
- description
- 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.
- interventionNames
- Diagnostic Test: Conventional CT
Primary outcomes (1)
- measure
- Change in management following randomized scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDTew 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 38102639
- DERIVEDDouglas 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 35777413