Could early antibiotic stop be safe for kids with cancer?

NCT ID NCT07590648

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

Up to 18 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, 28009, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046, Spain

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