Early versus late stopping of antibiotics for adults with high‑risk blood cancers or after stem‑cell or CAR T therapy who develop fever

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized intervention embeds an electronic medical record alert to prompt early cessation of empiric antibiotics in high‑risk hematology patients who develop fever after conditioning chemotherapy or induction for acute leukemia and whose fever has resolved for 48–96 hours. Participants are stratified by neutropenic status (ANC ≥500 versus <500 cells/mm3 at 48 hours) and followed to count recovery and clinical outcomes. The intervention standardizes care across transplant, CAR T and chemotherapy recipients and captures screening, randomization and data collection within routine clinical workflows. The trial is conducted at two major Melbourne tertiary centres and is designed to measure safety, antibiotic exposure, and subgroup outcomes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• Royal Melbourne Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Abby P Douglas, MBBS PhD FRACP — Peter MacCallum Cancer Centre; National Centre for Infections in Cancer
• Study coordinator: Principal Investigator
• Email: infectiousdiseases.clinicaltrials@petermac.org
• Phone: +61448503643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.