Actively Recruiting
Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies/Receiving Cellular Therapies and Fever (ELSA- Adult)
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-12-15
214
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
P
Peter MacCallum Cancer Centre, Australia
Lead Sponsor
M
Melbourne Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with high-risk blood cancers or those receiving cellular therapies who develop fever after chemotherapy, bone marrow transplantation, or CAR T-cell therapy. This study compares early stopping of antibiotics once fever resolves and the patient is stable, against the standard approach of continuing antibiotics until white blood cell counts recover. The goal is to see if reducing antibiotic use is safe and can lower risks like antibiotic resistance and side effects. This is the first Australian trial to explore this question using electronic medical records to enhance trial efficiency. Participants will be randomly assigned to one of two groups: the STOP group, where antibiotics start at fever onset but stop after 48-96 hours of no fever and clinical stability, and the SOC group, where antibiotics continue as usual until fever resolves and white blood cell counts rise above a specific level. The trial integrates alerts within electronic medical records to guide antibiotic management and stratifies patients based on their white blood cell counts to better understand outcomes in different subgroups. During the 28 days after randomization, patients remain hospitalized and are carefully monitored for fever recurrence, infections, intensive care admissions, and mortality. Researchers will track days without antibiotics, infection events, hospital stays, and readmissions. Safety is closely observed, with antibiotics restarted promptly if infection concerns arise. This approach aims to provide clear evidence on managing fever in high-risk patients while minimizing antibiotic exposure.
CONDITIONS
Brief Title
Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Receiving conditioning chemotherapy for autologous or allogeneic hematopoietic cell transplant or CAR T-cell therapy, OR induction remission chemotherapy for acute leukemia
- Developed fever of 38 degrees Celsius or higher between start of chemotherapy/conditioning and recovery of ANC to 500 cells/mm3
- Fever has resolved (below 38 degrees Celsius) for at least 48 hours and less than 96 hours
- Patients will be stratified based on ANC level at 48 hours after fever onset
You will not qualify if you...
- Prolonged fever lasting 5 or more days before fever resolution
- Positive blood culture for bacteria since fever onset before randomization
- Other documented infections requiring antibacterial treatment
- Grade 2 or higher mucositis or neutropenic enterocolitis
- Clinically unstable or admitted to ICU at randomization
- Randomized within the last 28 days
- Previous randomization during current chemotherapy cycle
- Pregnant or breastfeeding
- Currently treated for Grade 3 or 4 CRS or ICANS as per guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Until afebrile for 48-96 hours and clinically stable or until clinical recovery and ANC ≥200-500 cells/mm3
Participants will receive empiric antibiotic therapy starting at the onset of fever. Those in the early cessation group will stop antibiotics once afebrile for 48-96 hours and clinically stable. Those in the standard care group will continue antibiotics as per clinician discretion until clinical recovery and ANC ≥200-500 cells/mm3.
Duration depends on participant condition; antibiotic treatment and monitoring occur during hospitalization
Trial Site Locations
Total: 2 locations
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
2
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
Research Team
P
Principal Investigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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