Stopping antibiotics early in children with cancer and fever with low white blood cells
Tests stopping antibiotics early in children with cancer and high-risk febrile neutropenia.
Plain-language title generated from the registry record
Registry title: Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia
Key facts
- Where
- Barcelona, Esplugues de Llobregat, and Madrid, SpainSee the 4 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with cancer who have a high-risk fever with very low neutrophils (a type of white blood cell). They must be doing well 48-72 hours after the fever started and have low blood infection markers.
- Age
- 18 years or younger
- Sex
- All sexes can join.
- Disease stage
- Expected long-lasting low neutrophils (more than 7 days) with leukaemia, lymphoma or solid tumours on chemotherapy. Fever of 38.0°C (100.4 °F) or more with neutrophils below 500 per mm³, or expected to fall below this within 48-72 hours.
- Earlier treatment
- Antibiotics must have been started for the current fever episode. Routine antibiotic prophylaxis is allowed. Treatment must follow international guidelines.
- Biomarker or test result
- At the start: CRP below 9 mg/dL, PCT below 0.5 ng/mL, and no low blood pressure. At randomisation: CRP below 5 mg/dL, or CRP below 9 mg/dL with PCT below 0.5 ng/mL, and falling. Neutrophils below 500 per mm³.
Main reasons for not taking part
- Bacterial infection proven by lab tests 48-72 hours after the fever started
- Poor condition in the first 12 hours (unstable blood pressure, intensive care, death)
- Antibiotics different from the usual prophylaxis at the time of the fever, or different from international guidelines
- Taking part in another trial that may affect the results
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
- Hospital Sant Joan De DeuEsplugues de Llobregat, SpainNo longer taking part
- Hospital Infantil Universitario Nino JesusMadrid, SpainNo longer taking part
- Hospital Universitario La PazMadrid, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitari Vall d'Hebron Research Institute
- Trial code
- NCT07590648
- Record updated
- 15 May 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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; 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; 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); 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; No microbiologically documented bacterial infection 48-72 hours after the FN episode; 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); 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); ANC <500 neutrophils/mm³ at the time of randomisation; Signed informed consent from the patient and/or parent(s)/legal representative(s); 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; Patient and/or parent(s)/legal representative(s) must be considered reliable and capable of adhering to the protocol.
Exclusion: 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; 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; Active participation in another clinical trial that, in the investigators' opinion, may interfere with the assessment of the results; Female patients who are pregnant or breastfeeding.