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NCT07590648

PHASE4

Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Phase IV, Randomized, Open Label, Parallel Groups Clinical Trial for Evaluating the Early Stop of Antibiotic Treatment in High-risk Febrile Neutropenic Oncohaematological Paediatric Patients (e-STOP 2)

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2026-06-01

Completion Date

2028-07-01

Last Updated

2026-05-15

Healthy Volunteers

Conditions

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

Interventions

DRUG

Early Discontinuation of Antibiotics

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.

DRUG

Standard Antibiotic Continuation Strategy

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.

Inclusion Criteria: 1. Male and female patients ≤18 years of age expected to develop prolonged neutropenia (\>7 days), with: * 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 * B-cell and anaplastic lymphoma receiving high-intensity chemotherapy * Solid tumours receiving high-intensity chemotherapy * Relapsed leukaemia at any phase of treatment 2. Episode of febrile neutropenia (FN), defined as a single axillary temperature ≥38.0°C in a patient with an absolute neutrophil count (ANC) \<500 neutrophils/mm³, or expected to fall below this value within the next 48-72 hours. 3. Antibiotic treatment initiated for the current FN episode (routine antimicrobial prophylaxis is allowed, as well as teicoplanin 3 days/week for patients with AML included in the CHIP-AML-2022 protocol and therefore in the Pro-teico study). 4. Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following: * CRP \<9 mg/dL * PCT \<0.5 ng/mL * Absence of hypotension 5. No microbiologically documented bacterial infection 48-72 hours after the FN episode. 6. Good clinical evolution 48-72 hours after the FN episode, defined as: * Afebrile for \>48 hours (axillary temperature \<38°C) * Haemodynamically stable * Stable paediatric early warning score (PEWS) 7. CRP \<5 mg/dL, or CRP \<9 mg/dL and PCT \<0.5 ng/mL, with decreasing trend at the time of randomisation (values will be assessed on day 3 and day 5 after the FN episode). 8. ANC \<500 neutrophils/mm³ at the time of randomisation. 9. Signed informed consent from the patient and/or parent(s)/legal representative(s). 10. Patient and/or parent(s)/legal representative(s) must have sufficient reading and writing skills to understand and provide consent to participate in the study. 11. Patient and/or parent(s)/legal representative(s) must be considered reliable and capable of adhering to the protocol. Exclusion Criteria: 1. Antibiotic treatment at the time of the FN episode different from that used prophylactically. 2. Empirical antibiotic treatment different from that recommended in international guidelines. 3. Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death). 4. Active participation in the same study at the onset of the current FN episode. 5. Active participation in another clinical trial that, in the investigators' opinion, may interfere with the assessment of the results. 6. Any condition which, in the investigator's opinion, makes study participation unsuitable for the patient or could limit, prevent, or confound the assessments planned in the protocol. 7. Female patients who are pregnant or breastfeeding

Locations (4)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Spain

Hospital Universitario La Paz