Comparing early and late stopping of antibiotics in children with cancer and febrile neutropenia
Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia
This study is testing if stopping antibiotics early is just as safe as the usual practice of waiting until children with cancer and fever have fully recovered before stopping their antibiotics.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04948463 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate whether stopping empiric antibiotics before the recovery of absolute neutrophil count (ANC) is as safe as the standard practice of stopping antibiotics after ANC recovery in children with cancer experiencing high-risk febrile neutropenia (FN). The study will involve children who have been afebrile and clinically stable for at least 48 hours and will compare outcomes such as fever recurrence and new infections between the two groups. By utilizing a health informatics approach, the trial will integrate patient identification, consent, randomization, and outcome reporting within electronic medical records. The goal is to provide clearer guidance on antibiotic duration to reduce unnecessary exposure and associated risks.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with acute myeloid leukemia or acute lymphoblastic leukemia undergoing intensive treatment phases, or those within 100 days post hematopoietic stem cell transplantation with febrile neutropenia.
Not a fit: Patients with prolonged febrile neutropenia or documented infections requiring ongoing antibiotic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced antibiotic exposure and lower risks of side effects and complications in children with cancer.
How similar studies have performed: While there is limited evidence from observational studies and small trials, this approach is novel and aims to clarify conflicting guidelines on antibiotic cessation in febrile neutropenia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Melbourne, Victoria
- Royal Children's Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Gabrielle Haeusler — Murdoch Childrens Research Institute
- Study coordinator: Alannah Rudkin
- Email: alannah.rudkin@mcri.edu.au
- Phone: 03 8341 6200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.