Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia (NCT07590648) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia
Spain136 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients ≤18 years of age expected to develop prolonged neutropenia (\>7 days), with:
. 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:
. No microbiologically documented bacterial infection 48-72 hours after the FN episode.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite rate of adverse outcomes attributable to invasive or clinically significant bacterial infection
Timeframe: Day 0 (randomization) to Day 28
Trial details
NCT IDNCT07590648
SponsorHospital Universitari Vall d'Hebron Research Institute
. Good clinical evolution 48-72 hours after the FN episode, defined as:
. 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.
Exclusion criteria
. 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.
. 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.
. Female patients who are pregnant or breastfeeding