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ID07051525

Comparing Early Versus Standard Duration of Antibiotics in Adults With High-Risk Blood Cancers or Cellular Therapies and Fever

Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-12-15

214

Participants Needed

2

Research Sites

8 weeks

Total Duration

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

Research Team

P

Principal Investigator

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