Febrile NeutropeniaNCT05786495
Short Antibiotic Treatment in High Risk Febrile Neutropenia
A study testing Early Discontinuation of Antibiotics in people with Febrile Neutropenia, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population. Patients with cancer and low neutrophil counts due to chemotherapy or disease often have a fever and receive antibiotic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- Early Discontinuation of Antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Oct 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 years and older.
- The patient either has acute leukemia (AML, ALL or mixed-phenotypic acute leukemia) and is undergoing induction, re-induction or salvage chemotherapy or undergoing allogeneic HSCT and receiving conditioning chemotherapy and/or radiation.
- Documented febrile neutropenia as defined by the IDSA guidelines [1]:
- Single oral temperature of ≥38.3°C or at least two measurements of ≥38.0°C in an interval of ≥1 hour.
- ANC ≤ 0.5x109/L.
- Patient without a clinically or microbiologically documented infection (CDI/MDI).
Show all 15Show fewer
- We will require the following criteria to rule out infection:
- No focus of infection on a thorough history and physical examination at baseline and daily.
- Negative blood cultures after at least two sets of blood cultures have been taken. For example, the growth of coagulase-negative staphylococci, diphtheroids or Bacillus spp. from a single set will be considered contamination if another set of blood cultures is negative. Therefore, additional blood cultures will be taken in this case.
- Other cultures will be taken as indicated.
- A negative chest XR or CT scan (which will be performed according to the physician's discretion) for patients with symptoms of cough or chest pain.
- The subject will comply with the following criteria:
- Received empirical antibiotics for at least 72 hours AND
- Is afebrile for at least 24 hours AND
- Is still neutropenic (ANC ≤0.5x109/L).
Who cannot join
- Concurrent participation in another interventional trial.
- The patient has received empirical antibiotics for more than seven days from the onset of the febrile neutropenic episode.
- Septic shock at the onset of the episode or 72 hours (defined as persisting hypotension requiring vasopressors to maintain a MAP ≥ 65 mmHg and having a serum lactate level > 2 mmol/L despite adequate volume resuscitation).
- Patients with febrile neutropenia secondary to the treatment for solid malignancies, autologous HSCT, CAR-T cell therapy, hematologic malignancies besides acute leukemia when not in the context of allogeneic HSCT, AML treated with consolidation chemotherapy, or ALL treated with intensification and maintenance phase of chemotherapy.
- Clinically or microbiologically documented infections except for probable or proven invasive fungal disease diagnosed a-priori and treated.
- Patients receiving their induction chemotherapy or allogeneic HSCT as outpatients.
- We will not allow the enrollment of patients who have been previously enrolled in this study.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
Alberta Health Services
Edmonton
Dima Kabbani
- Recruiting
London Health Sciences Centre
London
Selay Lam
- Recruiting
University Health Network
Toronto
Roni Bitterman
- Recruiting
Vancouver General Hospital
Vancouver
Sara Belga
About this study
Official title: Early Discontinuation of Antibiotics for Unexplained Febrile Neutropenia: a Pilot Randomized Controlled Trial- EASE ANTIBIOTICS Pilot Trial
Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population. Patients with cancer and low neutrophil counts due to chemotherapy or disease often have a fever and receive antibiotic treatment. The optimal duration of this treatment is largely unknown. Late, there have been some data suggesting the safety of early discontinuation of antibiotics, though most centers still give more prolonged antibiotic therapies in this situation. The unnecessary prolonged antibiotic use may increase infections with multi-drug-resistant bacteria, which carry a high death rate. Also, an increase in infections caused by Clostridioides difficile and an increase in fungal infections can happen. However, some are concerned that stopping antibiotics while the neutrophil count is still low will result in life-threatening infections. Our study aims to test whether shorter antibiotic treatment in these situations is as safe as more prolonged treatment, resulting in better antibiotic prescription practices in this population.
Read the detailed description
Background Febrile neutropenia is a common complication of chemotherapy-induced neutropenia and neutropenia related to the disease. It occurs in 80% of patients with hematological malignancies with a significant impact on morbidity and mortality. The issue of antibiotic treatment duration in febrile neutropenia is unresolved. The rationale for continuing antibiotics until neutrophil recovery is based on the concern that neutropenic patients may have an ongoing risk of life-threatening infection, and neutropenia may conceal classical manifestations of infection. On the other hand, prolonged broad-spectrum antibiotic treatment has been associated with the emergence of antibiotic resistance, Clostridioides difficile infection and invasive fungal infections, as well as adverse effects and allergic reactions. The evidence suggesting the beneficial effects of prolonged antibiotic treatment is derived from 2 small randomized controlled trials (RCTs) from the 1970s, which showed an increase in infections and mortality with early stoppage of antibiotics. Two recently done RCTs, the HOW LONG and the SHORT studies, suggested that early discontinuation of antibiotics is feasible and is not associated with adverse outcomes. However, the first was not powered for safety outcomes and the second included a lower-risk population and a de-escalation strategy. Despite these reassuring studies, most centres still utilize the resolution of neutropenia as one of the criteria for stopping antibiotics in patients with febrile neutropenia.
Objective This pilot RCT will assess the feasibility of conducting a full future RCT. In the full trial, the investigators will compare early antibiotic discontinuation to the continuation of antibiotics until the resolution of neutropenia in high-risk febrile neutropenic patients, aiming to prove non-inferiority.
Methods The investigators will conduct a pilot open-label, multicentre RCT involving centres in Canada and Israel. The investigators will include adult patients with acute leukemia or patients undergoing allogeneic hematopoietic stem-cell transplantation diagnosed with febrile neutropenia of unknown source. Patients who have received antibiotics for at least 72 hours and are still neutropenic will be recruited if afebrile for at least 24 hours. Patients will be randomized to either early discontinuation or prolonged treatment in a 1:1 ratio using stratified, permuted block randomization. Patients randomized to the intervention arm will have antibiotics stopped at randomization, whereas those in the control group will receive antibiotics until resolution of neutropenia. The outcomes for this pilot study will be to assess the recruitment rate and understand the barriers to obtaining physician and patient consent; assess adherence to the allocated intervention and understand the reasons for crossovers; and measure primary outcome data for sample size re-estimation. This trial will serve as an internal pilot and the outcome data generated will contribute to the full trial. The primary outcome of the full trial will be a composite of all-cause mortality, transfer to intensive care units, or any clinically or microbiologically documented infection.
- Conditions
- Febrile Neutropenia
- Being tested
- Early Discontinuation of Antibiotics, Standard of Care
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Discontinuation of AntibioticsOther
Antibacterial treatment (i.e piperacillin/tazobactam, ceftazidime, cefepime, meropenem, vancomycin, amikacin, tobramycin, ciprofloxacin) will be stopped after 72 hours of treatment and defervescence for 24 hours, irrespective of neutrophil count
Standard of CareOther
Antibacterial treatment (i.e piperacillin/tazobactam, ceftazidime, cefepime, meropenem, vancomycin, amikacin, tobramycin, ciprofloxacin) will be continued until resolution of neutropenia
| Study group | Role | What they receive |
|---|---|---|
| Short treatment | Experimental | Antibiotic treatment will be stopped at the time of allocation to the intervention group Receives: Other: Early Discontinuation of Antibiotics |
| Prolonged treatment | Active comparator | Antibiotic treatment will be continued until the resolution of neutropenia (ANC > 0.5x109/L) Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
number of patients enroled per site per month
Measured: through study completion, approximately 2 years
Adherence
percentage of participants that adhered to the allocated intervention (meaning they stopped antibiotics within 2 days of the intervention they were randomized to)
Measured: 30 days from randomization
Complete outcome data
percentage of participants that were lost to follow up
Measured: 30 days from randomization
Secondary outcomes (15)
Rate of all-cause mortality
All-cause mortality
Measured: 30 days from randomization
Rate of transfer to the ICU
transfer to the intensive care unit will be derived from the participant's electronic health record
Measured: 30 days from randomization
Rate of any clinically or microbiologically documented infection
any clinically diagnosed infection (i.e pneumonia, intra-abdominal infection, skin-soft tissue infection when no bacteria was isolated) or any microbiologically documented infection (isolation of a bacteria/fungi from a sterile site with the exception of blood contaminants in a single blood culture or isolation of bacteria/fungi from a non-sterile site accompanied by a clinical syndrome). This will not include viral infections.
Measured: 30 days from randomization
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) analysis
DOOR for our study will be (ordinal outcome scale):
- The participant survived until day 30 without CDI, MDI or being transferred to ICU.
- The participant had a CDI or MDI but was not transferred to ICU, and they survived.
- The participant was transferred to ICU but survived.
- Death.
Measured: 30 days from randomization
total febrile days
total febrile days
Measured: 30 days from randomization
total antibiotic free days
total antibiotic free days
Measured: 30 days from randomization
recurrent fever resulting in restarting antibiotics
recurrent fever resulting in restarting antibiotics
Measured: 30 days from randomization
Rate of Clostridioides difficile associated diarrhea
loose stool (based on Bristol chart) and positive test for C. difficile in stool
Measured: 30 days from randomization
total in-hospital days
total in-hospital days
Measured: 30 days from randomization
readmission
readmission rates for any reason other than planned chemotherapy
Measured: 30 days from randomization
mold-active antifungal treatment
days of therapy with voriconazole, posaconazole, isavuconazole, echinocandins, amphotericin
Measured: 30 days from randomization
Development of an antibiotic resistant infection or colonization
defined as clinical isolates resistant to antibiotics previously used in the febrile episode or isolation of any of the bacteria below: extended-spectrum β-lactamase (ESBL) producing Enterobacterales, carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant Pseudomonas, carbapenem-resistant Acinetobacter baumannii, Stenotrophomonas maltophilia, methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) in both clinical and surveillance sampling
Measured: 30 days from randomization
Rate of adverse events
adverse events
Measured: 30 days from randomization
diversity of gut microbiome
diversity of gut microbiome will be measured using the Shannon index
Measured: 30 days from randomization
cost-effectiveness analysis
will acquire patient-level in-hospital costs from the finance departments of the participating hospitals
Measured: 30 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahid Husain, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786495
- Sponsor's protocol ID
- EASE ANTIBIOTICS pilot trial
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and statistical analysis plan will be shared directly after publication. Individual participant data that underlie the results reported in the article will be made available, after deidentification (text, tables, figures, and appendices), for other scientific research approved by an ethical board from 6 months until 24 months after article publication. The data will only be shared to achieve the aims of the approved proposal. Proposals should be directed to the Steering Committee of the clinical trial. Data requestors need to sign a data access agreement to gain access. After 24 months, the data will be available at the UHN without investigator support besides deposited metadata.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discontinuation of Antibiotics for Unexplained Febrile Neutropenia: a Pilot Randomized Controlled Trial- EASE ANTIBIOTICS Pilot Trial
- ClinicalTrials.gov ID
- NCT05786495
- Acronym / sponsor ID
- EASE ANTIBIOTICS pilot trial
- Conditions
- Febrile Neutropenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Mar 2023 (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.
Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population. Patients with cancer and low neutrophil counts due to chemotherapy or disease often have a fever and receive antibiotic treatment. The optimal duration of this treatment is largely unknown. Late, there have been some data suggesting the safety of early discontinuation of antibiotics, though most centers still give more prolonged antibiotic therapies in this situation. The unnecessary prolonged antibiotic use may increase infections with multi-drug-resistant bacteria, which carry a high death rate. Also, an increase in infections caused by Clostridioides difficile and an increase in fungal infections can happen. However, some are concerned that stopping antibiotics while the neutrophil count is still low will result in life-threatening infections. Our study aims to test whether shorter antibiotic treatment in these situations is as safe as more prolonged treatment, resulting in better antibiotic prescription practices in this population.
Detailed description
Background Febrile neutropenia is a common complication of chemotherapy-induced neutropenia and neutropenia related to the disease. It occurs in 80% of patients with hematological malignancies with a significant impact on morbidity and mortality. The issue of antibiotic treatment duration in febrile neutropenia is unresolved. The rationale for continuing antibiotics until neutrophil recovery is based on the concern that neutropenic patients may have an ongoing risk of life-threatening infection, and neutropenia may conceal classical manifestations of infection. On the other hand, prolonged broad-spectrum antibiotic treatment has been associated with the emergence of antibiotic resistance, Clostridioides difficile infection and invasive fungal infections, as well as adverse effects and allergic reactions. The evidence suggesting the beneficial effects of prolonged antibiotic treatment is derived from 2 small randomized controlled trials (RCTs) from the 1970s, which showed an increase in infections and mortality with early stoppage of antibiotics. Two recently done RCTs, the HOW LONG and the SHORT studies, suggested that early discontinuation of antibiotics is feasible and is not associated with adverse outcomes. However, the first was not powered for safety outcomes and the second included a lower-risk population and a de-escalation strategy. Despite these reassuring studies, most centres still utilize the resolution of neutropenia as one of the criteria for stopping antibiotics in patients with febrile neutropenia.
Objective This pilot RCT will assess the feasibility of conducting a full future RCT. In the full trial, the investigators will compare early antibiotic discontinuation to the continuation of antibiotics until the resolution of neutropenia in high-risk febrile neutropenic patients, aiming to prove non-inferiority.
Methods The investigators will conduct a pilot open-label, multicentre RCT involving centres in Canada and Israel. The investigators will include adult patients with acute leukemia or patients undergoing allogeneic hematopoietic stem-cell transplantation diagnosed with febrile neutropenia of unknown source. Patients who have received antibiotics for at least 72 hours and are still neutropenic will be recruited if afebrile for at least 24 hours. Patients will be randomized to either early discontinuation or prolonged treatment in a 1:1 ratio using stratified, permuted block randomization. Patients randomized to the intervention arm will have antibiotics stopped at randomization, whereas those in the control group will receive antibiotics until resolution of neutropenia. The outcomes for this pilot study will be to assess the recruitment rate and understand the barriers to obtaining physician and patient consent; assess adherence to the allocated intervention and understand the reasons for crossovers; and measure primary outcome data for sample size re-estimation. This trial will serve as an internal pilot and the outcome data generated will contribute to the full trial. The primary outcome of the full trial will be a composite of all-cause mortality, transfer to intensive care units, or any clinically or microbiologically documented infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment | Experimental | Other: Early Discontinuation of AntibioticsAntibiotic treatment will be stopped at the time of allocation to the intervention group |
| Prolonged treatment | Active comparator | Other: Standard of CareAntibiotic treatment will be continued until the resolution of neutropenia (ANC > 0.5x109/L) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 years and older.
- The patient either has acute leukemia (AML, ALL or mixed-phenotypic acute leukemia) and is undergoing induction, re-induction or salvage chemotherapy or undergoing allogeneic HSCT and receiving conditioning chemotherapy and/or radiation.
- Documented febrile neutropenia as defined by the IDSA guidelines [1]:
- Patient without a clinically or microbiologically documented infection (CDI/MDI).
- The subject will comply with the following criteria:
Key exclusion criteria (7 listed)
- Concurrent participation in another interventional trial.
- The patient has received empirical antibiotics for more than seven days from the onset of the febrile neutropenic episode.
- Septic shock at the onset of the episode or 72 hours (defined as persisting hypotension requiring vasopressors to maintain a MAP ≥ 65 mmHg and having a serum lactate level > 2 mmol/L despite adequate volume resuscitation).
- Patients with febrile neutropenia secondary to the treatment for solid malignancies, autologous HSCT, CAR-T cell therapy, hematologic malignancies besides acute leukemia when not in the context of allogeneic HSCT, AML treated with consolidation chemotherapy, or ALL treated with intensification and maintenance phase of chemotherapy.
- Clinically or microbiologically documented infections except for probable or proven invasive fungal disease diagnosed a-priori and treated.
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 Discontinuation of AntibioticsAntibacterial treatment (i.e piperacillin/tazobactam, ceftazidime, cefepime, meropenem, vancomycin, amikacin, tobramycin, ciprofloxacin) will be stopped after 72 hours of treatment and defervescence for 24 hours, irrespective of neutrophil count | Other | Short treatment |
| Standard of CareAntibacterial treatment (i.e piperacillin/tazobactam, ceftazidime, cefepime, meropenem, vancomycin, amikacin, tobramycin, ciprofloxacin) will be continued until resolution of neutropenia | Other | Prolonged treatment |
Primary outcome
Recruitment
Time frame: through study completion, approximately 2 years
number of patients enroled per site per month
Adherence
Time frame: 30 days from randomization
percentage of participants that adhered to the allocated intervention (meaning they stopped antibiotics within 2 days of the intervention they were randomized to)
Complete outcome data
Time frame: 30 days from randomization
percentage of participants that were lost to follow up
15 secondary outcomes
Rate of all-cause mortality
Time frame: 30 days from randomization
Rate of transfer to the ICU
Time frame: 30 days from randomization
Rate of any clinically or microbiologically documented infection
Time frame: 30 days from randomization
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) analysis
Time frame: 30 days from randomization
total febrile days
Time frame: 30 days from randomization
total antibiotic free days
Time frame: 30 days from randomization
recurrent fever resulting in restarting antibiotics
Time frame: 30 days from randomization
Rate of Clostridioides difficile associated diarrhea
Time frame: 30 days from randomization
total in-hospital days
Time frame: 30 days from randomization
readmission
Time frame: 30 days from randomization
mold-active antifungal treatment
Time frame: 30 days from randomization
Development of an antibiotic resistant infection or colonization
Time frame: 30 days from randomization
Rate of adverse events
Time frame: 30 days from randomization
diversity of gut microbiome
Time frame: 30 days from randomization
cost-effectiveness analysis
Time frame: 30 days from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Yes. The study protocol and statistical analysis plan will be shared directly after publication. Individual participant data that underlie the results reported in the article will be made available, after deidentification (text, tables, figures, and appendices), for other scientific research approved by an ethical board from 6 months until 24 months after article publication. The data will only be shared to achieve the aims of the approved proposal. Proposals should be directed to the Steering Committee of the clinical trial. Data requestors need to sign a data access agreement to gain access. After 24 months, the data will be available at the UHN without investigator support besides deposited metadata.
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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. This study is not recruiting at the moment.
Shahid Husain, MD principal investigator
University Health Network, Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Discontinuation of Antibiotics in people with Febrile Neutropenia, run by University Health Network, Toronto at 4 sites in Canada.
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 15 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahid Husain, MD (4163404800 ext. 2018, shahid.husain@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: through study completion, approximately 2 years). The study lists 3 primary outcomes in all. 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 17 Jul 2024.