NCT04948463CompletedPhase 4
Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 18 Jun 2021
- Start date
- 15 Nov 2021
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- Murdoch Childrens Research Institute
- Diseases
- Childhood cancers
- NCT number
- NCT04948463
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 55
- From 15 Nov 2021 to the primary completion date, 17 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented positive blood culture since onset of FN episode and prior to randomisation
- Documented other infection (microbiologically or clinically documented) requiring antibiotic treatment since onset of FN episode and prior to randomisation
- 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)
Other
- Prolonged febrile neutropenia (documented daily temperature ≥38.0°C for ≥5 days)
- Admitted to the ICU at the time of randomisation
- Within 28 days of last randomisation
Who the study is looking for
- 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
- Neutropenia (\<500 cells/mm3)
- 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)
- Commenced on empiric FN antibiotics (any of piperacillin-tazobactam, cefepime, ceftazidime or vancomycin and ciprofloxacin)
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Children's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.