Early versus late stopping of antibiotics for adults with high‑risk blood cancers or after stem‑cell or CAR T therapy who develop fever
Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies/Receiving Cellular Therapies and Fever (ELSA- Adult)
This trial tests if stopping antibiotics early is safe for adults with leukemia or after stem‑cell transplant or CAR T therapy when a fever has settled.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peter MacCallum Cancer Centre, Australia Academic / other |
| Drugs / interventions | CAR T, chemotherapy, Chimeric Antigen Receptor |
| Locations | 2 sites (Melbourne, Victoria and 1 other locations) |
| Trial ID | NCT07051525 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) receiving conditioning for autologous or allogeneic hematopoietic cell transplant, CAR T cell therapy, or induction chemotherapy for acute leukemia who develop fever during treatment and whose fever has been below 38°C for 48–96 hours are eligible.
Not a fit: Patients with documented bacterial bloodstream infection, other active documented infections, prolonged ongoing fever, or other exclusionary clinical features are unlikely to benefit from early cessation.
Why it matters
Potential benefit: If successful, patients could receive shorter antibiotic courses, reducing side effects and the risk of antibiotic resistance without increasing infectious complications.
How similar studies have performed: Earlier studies in lower‑risk or mixed populations have shown stopping antibiotics early can be safe in selected patients, but high‑risk groups (allograft recipients, prolonged neutropenia) have been underrepresented and this approach has not been tested in Australia.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Melbourne, Victoria and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.