Overview

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

Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
0
Participant gender:
All
Summary
This randomised controlled trial will determine the non-inferiority of stopping empiric antibiotics prior to absolute neutrophil count (ANC) recovery (Early Stopping) versus stopping antibiotics upon ANC recovery (Standard of Care/ Late Stopping) , in children with cancer and high-risk febrile neutropenia (FN).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Murdoch Childrens Research Institute
Treatments:
Amikacin
Cefepime
Ceftazidime
Ciprofloxacin
Piperacillin
Tazobactam
Vancomycin
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

- Lymphoma in induction or

- Any disease within 30 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 ≥7 day)

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