Clinical trial · Interventional
Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia
NCT04948463CI-TRIAL-00106167ELSA-FNcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amikacin Injection | Drug | — | UNRESOLVED |
| Cefepime Injection | Drug | — | UNRESOLVED |
| Ceftazidime Injection | Drug | — | UNRESOLVED |
| Ciprofloxacin | Drug | — | UNRESOLVED |
| Piperacillin and Tazobactam for Injection | Drug | — | UNRESOLVED |
| Vancomycin Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early Stopping
- description
- Stopping empiric FN antibiotics after resolution of fever for 48 hours, irrespective of absolute neutrophil count (ANC)
- interventionNames
- Drug: Piperacillin and Tazobactam for Injection
- Drug: Cefepime Injection
- Drug: Ceftazidime Injection
- Drug: Vancomycin Injection
- Drug: Amikacin Injection
- Drug: Ciprofloxacin
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Continuing empiric FN antibiotics until resolution of fever for 48 hours and recovery of ANC as defined by the treating clinician but usually to ≥200-500/mm3
- interventionNames
- Drug: Piperacillin and Tazobactam for Injection
- Drug: Cefepime Injection
- Drug: Ceftazidime Injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.