LeukemiaELSA-AdultNCT07051525
Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever
A study testing Early antibiotic cessation alert in people with Leukemia and CART Therapy, run by Peter MacCallum Cancer Centre, Australia at 2 sites in Australia.
Trial summary
Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, CART Therapy, Transplantation, Stem Cell
- What is being tested?
- Early antibiotic cessation alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesAustralia
- Study dates
- 3 Dec 2025to 5 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- - 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
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Infectious Diseases Clinical Trials Team, +61448503643, infectiousdiseases.clinicaltrials@petermac.org
Abby Douglas, MBBS PhD FRACP
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Infectious Diseases Clinical Trials team, +61448503643, infectiousdiseases.clinicaltrials@petermac.org
Monica A Slavin, MD MBBS PhD FRACP
About this study
Official title: Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies/Receiving Cellular Therapies and Fever (ELSA- Adult)
Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.
Read the detailed description
This study is designed to assess the safety, benefits and impacts of early cessation of empiric antibiotics in all fever (both pre-neutropenic (PNF) and neutropenic (NF)) that develops post conditioning or chemotherapy until count recovery in high-risk hematology patients who meet clear inclusion criteria. This is in recognition of the fact that both PNF and NF are often not infective in nature, and that cessation is likely an important and safe approach in both scenarios. Secondly, the patient's pre-neutropenic and neutropenic status is highly fluid and can rapidly change from one to the other (within a day), making strict definitions of neutropenia arbitrary and not particularly useful for implementation in the clinical setting. Furthermore, as a programmatic-type intervention that is embedded in clinical workflow, approaching high-risk patients with fever in a standardized way would enable consistency and inform clear and concise management protocols. Stratification will allow for assessment of each patient sub-group to provide more granular data.
As an Australian first, this study will exploit the full potential of electronic medical record (EMR) systems, embedding all key aspects of the trial including screening, randomization and data collection into standard clinical and EMR workflows. This highly novel and innovative clinical trial methodology has the potential to improve trial efficiency, data quality and transferability between healthcare centers and will systematically evaluate the barriers and enablers of embedded trials (ELSA-EMR).
The study hypothesizes that early cessation of antibiotics in adult patients with high risk fever is safe, acceptable, cost-effective and will minimize an unnecessarily prolonged health care intervention
- Being tested
- Early antibiotic cessation alert
- Keywords
- EPIC, ELSA, Febrile neutropaenia, Febrile neutropenia, antibitoics
- Medical subject headings
- Leukemia, Bacterial Infections, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early antibiotic cessation alertDrug
For all patients, antibiotics will be commenced at onset of fever. For those in the intervention arm an alert will fire in the electronic medical record once a patient is afebrile for 48-96 hours and clinically stable.
| Study group | Role | What they receive |
|---|---|---|
| STOP - early discontinuation of empiric antibiotic therapy | Experimental | Short course antibiotics (STOP): Antibiotics will be commenced at onset of fever and stopped once afebrile for 48-96 hours and clinically stable. Receives: Drug: Early antibiotic cessation alert |
| SOC - standard of care continuation of empiric antibiotic therapy | No intervention | Standard of care (SOC): Antibiotics will be commenced at onset of fever and continued for a duration as per clinician's discretion, typically until resolution of fever, clinical recovery and ANC ≥200- 500 cells/mm3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days free of antibiotic therapy in 28 days post randomization (termed empiric antibiotic free days (EAFDs))
The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. Measured as antibiotic free days in last 28 days post fever onset
Measured: 28 days after randomization
Secondary outcomes (18)
Days alive and free of antibiotic therapy in 28 days post randomization
Days alive and free of antibiotic therapy in 28 days post randomization
Measured: 28 days after randomization
Recurrence of fever (>38deg Celsius) beyond randomization
Recurrence of fever (>38deg Celsius, confirmed on second reading within 1 hour) post randomization during the same episode of neutropenia, not associated with blood product transfusion
- In CAR T treated patients, grade of cytokine release syndrome (CRS), immune-cell associated neurotoxicity (ICANS) at time of fever and any recurrent fever.
Measured: same episode of neutropenia - until ANC>500 cells/mm3
Number of occasions antibiotic therapy is recommenced with treatment intent
Number of events antibiotic therapy is recommenced with treatment intent (excluding prophylaxis)
Measured: Within 28 days after randomization
Days of antibiotic therapy during neutropenic period
Days of antibiotic therapy during neutropenic period until ANC>500 cells/mm3
Measured: Neutropenic period - until ANC>500 cells/mm3
Number of intensive care unit (ICU) admissions
Admission to intensive care for organ support during the same pre-neutropenic and neutropenic period post randomization
Measured: pre-neutropenic and neutropenic period post randomization (until ANC>500 cells/mm3)
Number of events of clinical instability
Number of events of clinical instability (defined by blood pressure, oxygen saturations, respiratory rate and heart rate meeting at least 1 Medical Emergency Team (MET) call criteria or 2 clinical review criteria)
Measured: 28 days after randomization
Number of events of new positive blood culture
Number of events of new positive blood culture post randomization (defined by CDC criteria)
Measured: 28 days after randomization
28 day all-cause mortality and infection-related mortality
28 day all-cause mortality and infection-related mortality (as assessed by an independent data safety monitoring board)
Measured: 28 days after randomization
Measure number of patient days of total hospital admission
Duration of in-hospital length of stay calculated from randomization date and time to discharge from hospital ward or Hospital-In-The-Home (HITH)
Measured: Measure number of days of total hospital length of stay during enrolment (admission until discharge from hospital inpatient and HITH)
Total number of days of in-hospital length of stay
Duration of in-hospital length of stay calculated from randomization date and time to discharge/transfer from in- hospital ward
Measured: Total number of days of in-hospital length of stay
Total hospital length of stay post randomisation
Duration of in-hospital length of stay calculated from randomization date and time to discharge from hospital ward or HITH
Measured: Total hospital length of stay post randomization to discharge (from ward or HITH)
Number of unplanned hospital readmissions
Unplanned readmission to hospital within 60 days of randomization, defined as any admission that is not due to planned chemotherapy, conditioning or routine neutropenic monitoring as per standard protocols.
Measured: within 60 days of randomization
Number of positive C.difficile infections
Number of development of C.difficile infection (defined by diarrhea, positive toxin polymerase chain reaction (PCR) and lack of other cause) within 6 months of randomization
Measured: within 6 months of randomization
Number of antibiotic resistant infection or colonizations
New antibiotic resistant (Methicillin-resistant Staphylococcus aureus (MRSA), Extended-Spectrum Beta-Lactamases (ESBL) producing Enterobacterales, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE) infection or colonization detected within 180 days post randomization
Measured: within 180 days post randomization
Number of Clinically defined infections during pre-neutropenic and neutropenic period
Number of Clinically defined infections during pre-neutropenic and neutropenic period
Measured: pre-neutropenic and neutropenic period until ANC>500 cells/mm3
Number of clinically defined infections post randomization
Number of clinically defined infections post randomization
Measured: post randomization until 28days
Number of microbiologically defined infections during pre-neutropenic and neutropenic period
Number of microbiologically defined infections during pre-neutropenic and neutropenic period
Measured: during pre-neutropenic and neutropenic period until ANC>500 cells/mm3
Number of microbiologically defined infections post randomization
Number of microbiologically defined infections post randomisation
Measured: post randomization until 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start3 Dec 2025
- Primary completion5 Dec 2027 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention: Early discontinuation of empiric antibiotic therapy: ceasing antibiotics upon meeting all inclusion and no exclusion criteria Control: Standard of care: Continuing empiric antibiotics beyond resolution of fever for at least 96 hours and otherwise as per clinician's discretion (typically recovery of absolute neutrophil count (ANC) to \>200 cells/mm3)
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health
- Responsible party
- Sponsor
- Investigators
- Abby P Douglas, MBBS PhD FRACP, Principal investigator, Peter MacCallum Cancer Centre; National Centre for Infections in Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051525
- Sponsor's protocol ID
- 24/236
- Other IDs
- 2024.406, ERM113654
- Acronym
- ELSA-Adult
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies/Receiving Cellular Therapies and Fever (ELSA- Adult)
- ClinicalTrials.gov ID
- NCT07051525
- Acronym / sponsor ID
- ELSA-Adult / 24/236
- Keywords
- EPIC, ELSA, Febrile neutropaenia, Febrile neutropenia, antibitoics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- Melbourne Health
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.
Detailed description
This study is designed to assess the safety, benefits and impacts of early cessation of empiric antibiotics in all fever (both pre-neutropenic (PNF) and neutropenic (NF)) that develops post conditioning or chemotherapy until count recovery in high-risk hematology patients who meet clear inclusion criteria. This is in recognition of the fact that both PNF and NF are often not infective in nature, and that cessation is likely an important and safe approach in both scenarios. Secondly, the patient's pre-neutropenic and neutropenic status is highly fluid and can rapidly change from one to the other (within a day), making strict definitions of neutropenia arbitrary and not particularly useful for implementation in the clinical setting. Furthermore, as a programmatic-type intervention that is embedded in clinical workflow, approaching high-risk patients with fever in a standardized way would enable consistency and inform clear and concise management protocols. Stratification will allow for assessment of each patient sub-group to provide more granular data.
As an Australian first, this study will exploit the full potential of electronic medical record (EMR) systems, embedding all key aspects of the trial including screening, randomization and data collection into standard clinical and EMR workflows. This highly novel and innovative clinical trial methodology has the potential to improve trial efficiency, data quality and transferability between healthcare centers and will systematically evaluate the barriers and enablers of embedded trials (ELSA-EMR).
The study hypothesizes that early cessation of antibiotics in adult patients with high risk fever is safe, acceptable, cost-effective and will minimize an unnecessarily prolonged health care intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention: Early discontinuation of empiric antibiotic therapy: ceasing antibiotics upon meeting all inclusion and no exclusion criteria Control: Standard of care: Continuing empiric antibiotics beyond resolution of fever for at least 96 hours and otherwise as per clinician's discretion (typically recovery of absolute neutrophil count (ANC) to >200 cells/mm3)
| Arm | Type | Receives |
|---|---|---|
| STOP - early discontinuation of empiric antibiotic therapy | Experimental | Drug: Early antibiotic cessation alertShort course antibiotics (STOP): Antibiotics will be commenced at onset of fever and stopped once afebrile for 48-96 hours and clinically stable. |
| SOC - standard of care continuation of empiric antibiotic therapy | No intervention | –Standard of care (SOC): Antibiotics will be commenced at onset of fever and continued for a duration as per clinician's discretion, typically until resolution of fever, clinical recovery and ANC ≥200- 500 cells/mm3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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]
Key exclusion criteria (9 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early antibiotic cessation alertFor all patients, antibiotics will be commenced at onset of fever. For those in the intervention arm an alert will fire in the electronic medical record once a patient is afebrile for 48-96 hours and clinically stable. | Drug | STOP - early discontinuation of empiric antibiotic therapy |
Primary outcome
Days free of antibiotic therapy in 28 days post randomization (termed empiric antibiotic free days (EAFDs))
Time frame: 28 days after randomization
The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. Measured as antibiotic free days in last 28 days post fever onset
18 secondary outcomes
Days alive and free of antibiotic therapy in 28 days post randomization
Time frame: 28 days after randomization
Recurrence of fever (>38deg Celsius) beyond randomization
Time frame: same episode of neutropenia - until ANC>500 cells/mm3
Number of occasions antibiotic therapy is recommenced with treatment intent
Time frame: Within 28 days after randomization
Days of antibiotic therapy during neutropenic period
Time frame: Neutropenic period - until ANC>500 cells/mm3
Number of intensive care unit (ICU) admissions
Time frame: pre-neutropenic and neutropenic period post randomization (until ANC>500 cells/mm3)
Number of events of clinical instability
Time frame: 28 days after randomization
Number of events of new positive blood culture
Time frame: 28 days after randomization
28 day all-cause mortality and infection-related mortality
Time frame: 28 days after randomization
Measure number of patient days of total hospital admission
Time frame: Measure number of days of total hospital length of stay during enrolment (admission until discharge from hospital inpatient and HITH)
Total number of days of in-hospital length of stay
Time frame: Total number of days of in-hospital length of stay
Total hospital length of stay post randomisation
Time frame: Total hospital length of stay post randomization to discharge (from ward or HITH)
Number of unplanned hospital readmissions
Time frame: within 60 days of randomization
Number of positive C.difficile infections
Time frame: within 6 months of randomization
Number of antibiotic resistant infection or colonizations
Time frame: within 180 days post randomization
Number of Clinically defined infections during pre-neutropenic and neutropenic period
Time frame: pre-neutropenic and neutropenic period until ANC>500 cells/mm3
Number of clinically defined infections post randomization
Time frame: post randomization until 28days
Number of microbiologically defined infections during pre-neutropenic and neutropenic period
Time frame: during pre-neutropenic and neutropenic period until ANC>500 cells/mm3
Number of microbiologically defined infections post randomization
Time frame: post randomization until 28days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abby P Douglas, MBBS PhD FRACP principal investigator
Peter MacCallum Cancer Centre; National Centre for Infections in Cancer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early antibiotic cessation alert in people with Leukemia and CART Therapy, run by Peter MacCallum Cancer Centre, Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (+61448503643, infectiousdiseases.clinicaltrials@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days free of antibiotic therapy in 28 days post randomization (termed empiric antibiotic free days (EAFDs)) (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.