Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Jul 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best time to stop antibiotics in children with cancer who have a condition called febrile neutropenia, which means they have a fever and a low number of white blood cells that help fight infections. The trial compares two approaches: stopping antibiotics early, before the blood cell count comes back to normal, versus the usual practice of stopping them only after the blood cell count recovers. The goal is to find out if stopping antibiotics early is just as safe and effective.

To be eligible for this trial, participants should be children diagnosed with specific types of leukemia or those who have recently undergone a stem cell transplant. They should also have a low white blood cell count and have been fever-free for at least two days after having a fever. If eligible, participants will receive either early or late stopping of antibiotics and will be monitored closely for their health during the trial. It’s important to note that children with certain severe infections or those currently needing intensive care may not be able to join. This study aims to improve care for young patients with cancer by finding the best way to manage antibiotic treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of
• • Acute myeloid leukemia (AML) or acute lymphoblastic leukaemia (ALL) in dose-intensive phases of induction/re-induction, intensification or consolidation or
• • ALL or acute lymphoblastic lymphoma patients on a TOT17 protocol or
• • Any disease within 100 days of allogeneic or autologous HSCT
• • 2. Neutropenia (\<500 cells/mm3)
• • 3. Afebrile (temperature \<38.0°C) period for at least 48 hours and no more than 96 hours after at least one temperature measured by axillary or tympanic thermometer (≥38.0°C)
• • 4. Commenced on empiric FN antibiotics (any of piperacillin-tazobactam, cefepime, ceftazidime or vancomycin and ciprofloxacin)
• Exclusion Criteria:
• • 1. Prolonged febrile neutropenia (documented daily temperature ≥38.0°C for ≥5 days)
• • 2. Documented positive blood culture since onset of FN episode and prior to randomisation
• • 3. Documented other infection (microbiologically or clinically documented) requiring antibiotic treatment since onset of FN episode and prior to randomisation
• • 4. Admitted to the ICU at the time of randomisation
• • 5. Clinical instability (One or more conscious state, respiratory rate, blood pressure, heart rate or oxygen saturations in MET criteria OR two or more respiratory rate, blood pressure, heart rate or oxygen saturations simultaneously (+/- 4 hrs) in the clinical review criteria in 48 hours prior to randomisation)
• • 6. Within 28 days of last randomisation