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Can kids with cancer stop antibiotics sooner? new trial investigates

NCT ID NCT04948463

Disease control Sponsor: Murdoch Childrens Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether children with cancer and a fever caused by low white blood cells can safely stop antibiotics earlier than usual. 55 children took part, and half stopped antibiotics once their fever was gone for 48 hours, while the other half continued until their white blood cells recovered. The goal was to see if early stopping leads to similar or better outcomes.

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, cefepime, ceftazidime, vancomycin)
What this could lead to
If successful, this could allow children with cancer to stop antibiotics sooner, reducing side effects and hospital stays.
What could go wrong
This is a small, early-phase trial with only 55 participants, so results may not apply to all children. Early stopping could lead to fever or infection returning.

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

55 people

The number who actually took part.

Started

Nov 2021

Finished

Dec 2025

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. Diagnosis of * Acute myeloid leukemia (AML) or acute lymphoblastic leukaemia (ALL) in dose-intensive phases of induction/re-induction, intensification or consolidation or * ALL or acute lymphoblastic lymphoma patients on a TOT17 protocol or * Any disease within 100 days of allogeneic or autologous HSCT 2. Neutropenia (\<500 cells/mm3) 3. Afebrile (temperature \<38.0°C) period for at least 48 hours and no more than 96 hours after at least one temperature measured by axillary or tympanic thermometer (≥38.0°C) 4. Commenced on empiric FN antibiotics (any of piperacillin-tazobactam, cefepime, ceftazidime or vancomycin and ciprofloxacin) Exclusion Criteria: 1. Prolonged febrile neutropenia (documented daily temperature ≥38.0°C for ≥5 days) 2. Documented positive blood culture since onset of FN episode and prior to randomisation 3. Documented other infection (microbiologically or clinically documented) requiring antibiotic treatment since onset of FN episode and prior to randomisation 4. Admitted to the ICU at the time of randomisation 5. Clinical instability (One or more conscious state, respiratory rate, blood pressure, heart rate or oxygen saturations in MET criteria OR two or more respiratory rate, blood pressure, heart rate or oxygen saturations simultaneously (+/- 4 hrs) in the clinical review criteria in 48 hours prior to randomisation) 6. Within 28 days of last randomisation

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia Febrile Neutropenia lymphoblastic lymphoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Febrile neutropenia

Contacts and locations

Locations

  • Royal Children's Hospital

    Melbourne, Victoria, 3052, Australia

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