ArticleEClinicalMedicine2025
Early stoppage of empirical antibiotic therapy in paediatric acute leukaemia with high-risk febrile neutropenia: a randomized, open-label, phase 3, non-inferiority trial.
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Empirical antibiotic therapy (EAT) is commonly continued until recovery of neutrophil counts in paediatric acute leukaemia with high-risk febrile neutropenia. This study assessed whether early discontinuation of EAT was non-inferior to the continuation of EAT until absolute neutrophil count (ANC) ≥500/μL among children with high-risk febrile neutropenia. Methods: This open-label, phase 3, non-inferiority, randomized trial was conducted between October 2018 and August 2024 and enrolled children aged 2-18 years with acute leukaemia experiencing high-risk febrile neutropenia during induction chemotherapy. Patients clinically stable and afebrile for ≥72 h on EAT, with ANC <500/μL and no documented infection, were randomized to either stop EAT or continue it until ANC ≥500/μL. The primary outcome was proportion of fever recurrence, with a non-inferiority margin of 15 percentage points. Secondary outcomes included antibiotic duration, hospital readmissions, use of third-line antibiotics, use of therapeutic antifungals, and mortality. This study is registered at Clinical Trial Registry of India (CTRI/2018/015994). Findings: Of 280 patients randomized, 278 were analysed (140 stop arm, 138 continuation arm). Median age (IQR) was 8 (5-14) years, with 34.2% being female. Fever recurrence occurred in 52.1% (73/170) and 47.1% (65/138) children in stop and continuation arms respectively. The difference in fever recurrence between the arms was 5.0 percentage points (90% CI: -4.8 to 14.8 percentage points), establishing non-inferiority of the stop arm. The median (IQR) days of EAT after randomization were shorter in the stop arm [4.2 (0-10) vs 11 (7.2-15); p < 0.0001]. Mortality, hospital readmission, third-line antibiotic use, or therapeutic antifungal use did not differ between the two arms. Interpretation: Early discontinuation of EAT in paediatric acute leukaemia with high-risk febrile neutropenia was non-inferior to continuation of EAT until recovery of ANC. Funding: None.
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