A Phase 4 interventional study of Early Discontinuation of Antibiotics and Standard Antibiotic Continuation Strategy in Febrile Neutropenia (FN), Pediatric Cancer and Hematologic Malignancies, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 4 sites in Spain. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 4, Interventional, and Treatment
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.
Children with cancer who develop febrile neutropenia (FN) routinely receive broad-spectrum intravenous antibiotics to prevent severe bacterial infections. Although this approach is essential in high-risk cases, prolonged antibiotic exposure increases the risk of adverse effects, antimicrobial resistance, drug toxicity, and longer hospital stays. Advances in risk stratification-particularly through clinical stability assessment and biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT)-now allow earlier identification of patients who may no longer require intensive antibiotic coverage.
This study evaluates whether early discontinuation of antibiotic therapy is safe in paediatric patients with cancer who present high-risk FN but show a favourable clinical course 48-72 hours after onset. Eligible patients must meet predefined criteria indicating low risk of invasive bacterial infection (IBI), including clinical stability, absence of microbiologically documented infection, and decreasing biomarker levels. The trial uses a randomised, controlled, open-label design to compare an early-stop strategy with the current standard management.
The rationale for this approach is to determine whether antibiotic therapy can be safely shortened without compromising infection-related outcomes. Limiting unnecessary antibiotic exposure may reduce adverse drug events, improve patient comfort, minimise disruption of the microbiome, and support antimicrobial stewardship programmes. The study also incorporates biomarker measurements (CRP, PCT, IL-8) to explore their predictive value for IBI and to validate an IBI-risk prediction model for this population.
Participants will be monitored closely for signs of bacterial infection or clinical deterioration throughout the 28-day follow-up period. This design enables robust assessment of safety while reflecting real-world clinical decision-making and the potential benefits of personalised antibiotic duration in paediatric oncology care.
151 studies on the registry are indexed under Febrile Neutropenia; 33 are open to participants now.
This study's planned enrollment of 136 is above the median of 120 across 90 interventional studies indexed under Febrile Neutropenia.
Browse Febrile Neutropenia studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female patients ≤18 years of age expected to develop prolonged neutropenia (>7 days), with:
Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following:
Good clinical evolution 48-72 hours after the FN episode, defined as:
Exclusion Criteria:
Participants assigned to this arm will have intravenous antibiotic therapy discontinued within 24 hours after randomization, provided they meet all clinical stability and low-risk criteria. Patients may be discharged if no other clinical reasons require hospitalization. Antibiotics may be reintroduced if fever recurs or if clinical deterioration suggests infection.
Drug: Early Discontinuation of Antibiotics
Participants assigned to this arm will continue antibiotic therapy for at least 7 days and/or until signs of marrow recovery are present (ANC ≥100/mm³), according to each center's standard protocol. Hospital discharge will occur once clinical criteria permit.
Drug: Standard Antibiotic Continuation Strategy
Participants 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.
Also known as: Drug stop within 24 hours after randomization:Piperacillin-tazobactam, amikacin, meropenem, cefepime, ceftazidime, vancomycin, teicoplanin, ciprofloxacin, levofloxacine and metronidazole
Continuation 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.
Also known as: Drug continuation for at least 7d and/or until marrow recovery:Piperacillin-tazobactam,amikacin,meropenem,cefepime, ceftazidime, vancomycin, teicoplanin, ciprofloxacin, levofloxacine and metronidazole
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.
Time frame: Day 0 (randomization) to Day 28
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.
Time frame: From Day 0 to Day 28
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.
Time frame: Up to Day 28
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.
Time frame: Measured at episode onset, at 48-72 hours, and optionally on Day 5
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.
Time frame: Measured at episode onset, at 48-72 hours, and optionally on Day 5
Predictive performance of interleukin-8 (IL-8) for invasive bacterial infection
Retrospective evaluation of IL-8 levels as a predictor of invasive bacterial infection in pediatric high-risk febrile neutropenia episodes.
Time frame: Measured at episode onset and at 48-72 hours
Validation of an invasive bacterial infection (IBI) prediction model
Evaluation of a predictive model combining clinical variables, biomarker measurements, and risk scores to classify pediatric high-risk febrile neutropenia episodes according to risk of invasive bacterial infection.
Time frame: Day 0 to Day 28
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute