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.
Parallel
Early Discontinuation of Antibiotics
DrugParticipants assigned to this intervention will stop intravenous antibiotic therapy within 24 hours after randomization, provided they meet all required clinical stability and low-risk criteria at 48-72 hours (or day 5) after the febrile neutropenia episode. Patients may be discharged once clinically appropriate. Antibiotics may be restarted if fever recurs or clinical deterioration suggests infection.
Standard Antibiotic Continuation Strategy
DrugContinuation of antibiotic therapy for at least 7 days and/or until marrow recovery (ANC ≥100/mm³) following standard institutional protocols. Therapy may be extended depending on clinical assessment.
Composite rate of adverse outcomes attributable to invasive or clinically significant bacterial infection
Composite endpoint including any of the following events: death, pediatric intensive care unit admission, sepsis or septic shock, microbiologically documented bacterial infection, or radiologically confirmed pneumonia. The proportion of participants experiencing at least one component of the composite endpoint will be compared between the early discontinuation arm and the standard continuation arm to assess non-inferiority in safety.
Number of days of antibiotic therapy
Total duration of systemic antimicrobial therapy will be compared between the early-stop arm and the standard-therapy arm to evaluate reduction in antibiotic exposure.
Incidence of antibiotic-related adverse events
Number of participants experiencing adverse effects attributable to antimicrobial therapy, including drug toxicity or complications associated with prolonged antibiotic use.
Predictive performance of C-reactive protein (CRP) for invasive bacterial infection
Retrospective evaluation of CRP levels as a predictor of invasive bacterial infection in pediatric high-risk febrile neutropenia episodes.
Predictive performance of procalcitonin (PCT) for invasive bacterial infection
Retrospective evaluation of procalcitonin levels as a predictor of invasive bacterial infection in pediatric high-risk febrile neutropenia episodes.
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This trial is not recruiting at the moment. You can still explore other options:
