The goal of this clinical trial is to evaluate whether stopping antibiotic treatment early is safe in paediatric patients with cancer who develop high-risk febrile neutropenia but show good clinical evolution and low biomarker levels 48-72 hours after the episode.
The main questions it aims to answer are:
Is early discontinuation of antibiotics as safe as the standard strategy in terms of preventing invasive bacterial infections (such as sepsis, microbiologically documented infection, ICU admission, or death)? Does this strategy reduce the number of days on antibiotics without increasing infection-related complications?
Researchers will compare early antibiotic discontinuation with the standard care strategy to see whether the early-stop approach provides similar safety while reducing antibiotic exposure.
Participants will:
Receive standard initial antibiotic therapy for febrile neutropenia. Undergo clinical and biomarker evaluations (including CRP and PCT).
Be randomly assigned to:
Experimental group: early discontinuation of antibiotics, or Control group: continuation of the standard antibiotic strategy.
Be followed for 28 days after randomisation to monitor safety outcomes and treatment effects.
Acute myeloblastic leukaemia at any phase of chemotherapy
Acute lymphoblastic leukaemia in induction, consolidation, or intensification phases
Biphenotypic leukaemia at any phase of chemotherapy
Lymphoblastic lymphoma in induction and consolidation phases
Antibiotic treatment at the time of the FN episode different from that used prophylactically.
Empirical antibiotic treatment different from that recommended in international guidelines.
Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).
Active participation in the same study at the onset of the current FN episode.