Could early antibiotic stop be safe for kids with cancer?
NCT ID NCT07590648
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial looks at whether children with cancer who develop a fever and low white blood cells can safely stop antibiotics earlier than usual. About 136 children will be randomly assigned to either stop antibiotics within 24 hours or continue standard treatment. The goal is to see if early stopping reduces antibiotic use without increasing serious infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- antibiotics (piperacillin-tazobactam, amikacin, meropenem, cefepime, ceftazidime, vancomycin, teicoplanin, ciprofloxacin, levofloxacin, metronidazole)
- What this could lead to
- If successful, this could show that stopping antibiotics early is safe for certain children with cancer, reducing unnecessary antibiotic use and side effects.
- What could go wrong
- This is a relatively small Phase 4 trial (136 participants) and only includes children who meet strict stability criteria. Results may not apply to all patients, and there is a risk of missed infections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009, Spain
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Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
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Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
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