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Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever

RecruitingNAAges 18 Years - anyAllPeter MacCallum Cancer Centre, Australia
NCT07051525 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) a

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📋 Eligibility rules (as published)
Inclusion Criteria: Adult patients ( ≥18 years) who are receiving either: * Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR * Induction remission chemotherapy for acute leukaemia, AND develop fever ( ≥38degC) between time of initiation of chemotherapy/conditioning administration and ANC recovery to ≥500 cells/mm3 post the ANC nadir, AND fever subsequently has settled (\<38degC) for ≥48 and \<96h hours. \[participants will be stratified into pre-neutropenic (ANC ≥500 cells/mm3) and neutropenic (ANC\<500 cells/mm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\] Exclusion Criteria: * \- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days) * Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation * Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment * Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis * Clinically unstable and/or admission to ICU at time of potential randomization * Within 28 days of last randomization * Prior randomization during current chemotherapy/conditioning cycle * Pregnant or breastfeeding * Currently being treated for CRS Grade 3 or 4, and/or ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)
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What it tests

  • Early antibiotic cessation alert
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Where

2 sites
Peter MacCallum Cancer Centre
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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