Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT07590648
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Febrile Neutropenia (FN)
  • Hematologic Malignancies
  • Invasive Bacterial Infection
  • Pediatric Cancer
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Early Discontinuation of Antibiotics — DRUG
    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.
  • Standard Antibiotic Continuation Strategy — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 15, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Discontinuation of Antibiotics
    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.
  • Active Comparator: Standard Antibiotic Strategy
    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.

Primary Outcome Measure

Composite rate of adverse outcomes attributable to invasive or clinically significant bacterial infection [ Time Frame: Day 0 (randomization) to Day 28 ]

Central Contacts

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