RecruitingNot ApplicableNCT07051525

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

Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies/Receiving Cellular Therapies and Fever (ELSA- Adult)


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

214 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether it is safe to stop antibiotics earlier in patients who had a fever during intensive chemotherapy (for blood cancers or before a stem cell transplant or CAR T-cell therapy) once the fever has resolved. The goal is to reduce unnecessary antibiotic use while maintaining safety. **You may be eligible if:** - You are 18 or older - You are receiving chemotherapy for acute leukemia, or conditioning chemotherapy before a stem cell transplant or CAR T-cell therapy - You developed a fever (38°C or higher) during treatment - Your fever has been gone (below 38°C) for at least 48 hours but less than 96 hours **You may NOT be eligible if:** - Your fever lasted 5 or more days in a row before settling - Your blood cultures came back positive for bacteria - You have a confirmed or suspected infection requiring continued antibiotics - You have moderate to severe mouth sores or a bowel inflammation - You are clinically unstable or in an ICU - You were randomized in this trial within the past 28 days - You are pregnant or breastfeeding - You have severe cytokine release syndrome or neurotoxicity (grades 3–4) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEarly antibiotic cessation alert

For all patients, antibiotics will be commenced at onset of fever. For those in the intervention arm an alert will fire in the electronic medical record once a patient is afebrile for 48-96 hours and clinically stable.


Locations(2)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

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NCT07051525


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