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Could early antibiotic stop be safe for high-risk blood cancer patients?

NCT ID NCT07051525

Disease control Sponsor: Peter MacCallum Cancer Centre, Australia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether it is safe to stop antibiotics early in adults with high-risk blood cancers or those who have had stem cell transplants or CAR T-cell therapy. Participants will be randomly assigned to stop antibiotics once their fever goes away or continue until their white blood cell count recovers. The goal is to reduce antibiotic use and side effects while keeping patients safe in the hospital.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 214 people

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

Started

Dec 2025

Expected to finish

Feb 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

18 years and older

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: Adult patients ( ≥18 years) who are receiving either: * Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR * Induction remission chemotherapy for acute leukaemia, AND develop fever ( ≥38degC) between time of initiation of chemotherapy/conditioning administration and ANC recovery to ≥500 cells/mm3 post the ANC nadir, AND fever subsequently has settled (\<38degC) for ≥48 and \<96h hours. \[participants will be stratified into pre-neutropenic (ANC ≥500 cells/mm3) and neutropenic (ANC\<500 cells/mm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\] Exclusion Criteria: * \- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days) * Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation * Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment * Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis * Clinically unstable and/or admission to ICU at time of potential randomization * Within 28 days of last randomization * Prior randomization during current chemotherapy/conditioning cycle * Pregnant or breastfeeding * Currently being treated for CRS Grade 3 or 4, and/or ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)

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Conditions

The condition(s) this trial relates to.

acute leukemia bacterial infectious disease Febrile Neutropenia leukemia

As listed by the trial registrant

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

Cart therapy Infections - bacterial Leukemia Transplantation, stem cell

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 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

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, 3050, Australia

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