Actively Recruiting
Early Discontinuation of Antibiotics for Unexplained Febrile Neutropenia: a Pilot Randomized Controlled Trial- EASE ANTIBIOTICS Pilot Trial
Led by University Health Network, Toronto · Updated on 2024-07-17
80
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Febrile neutropenia is a common and serious complication in patients with acute leukemia or those undergoing allogeneic hematopoietic stem-cell transplantation. It involves fever and low neutrophil counts due to chemotherapy or disease. Researchers are evaluating whether stopping antibiotic treatment early in these patients is as safe as continuing antibiotics until neutrophil recovery. This pilot randomized controlled trial aims to test the feasibility of a larger study comparing these two antibiotic treatment durations to improve prescription practices and reduce risks associated with prolonged antibiotic use, such as resistant infections and fungal infections. Participants in this study will receive antibiotic treatment for at least 72 hours and be afebrile for at least 24 hours while still neutropenic. They will be randomly assigned to either stop antibiotics early at the time of randomization or continue antibiotics until their neutrophil counts recover. The study will be conducted at multiple centers and involves close monitoring of antibiotic use and patient outcomes. This pilot trial also aims to assess recruitment and adherence to the treatment plan to inform a future larger trial. During the study, participants will be monitored for outcomes such as mortality, transfer to intensive care units, and documented infections. Researchers will collect data on antibiotic-free days, fever recurrence, adverse events, and infections with resistant bacteria or Clostridioides difficile over 30 days after randomization. The study will also analyze cost-effectiveness and changes in gut microbiome diversity. Participants' adherence to the assigned treatment and safety outcomes will be closely tracked throughout the approximately two-year recruitment and follow-up period.
CONDITIONS
Brief Title
Short Antibiotic Treatment in High Risk Febrile Neutropenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Diagnosed with acute leukemia (AML, ALL, or mixed-phenotypic acute leukemia) undergoing induction, re-induction, salvage chemotherapy, or allogeneic HSCT with conditioning chemotherapy and/or radiation
- Documented febrile neutropenia as defined by IDSA guidelines: single oral temperature ≥38.3°C or two measurements ≥38.0°C at least 1 hour apart, and ANC ≤0.5x10^9/L
- No clinically or microbiologically documented infection as confirmed by history, physical exam, negative blood cultures, and negative chest imaging if indicated
- Received empirical antibiotics for at least 72 hours
- Afebrile for at least 24 hours
- Still neutropenic (ANC ≤0.5x10^9/L)
You will not qualify if you...
- Concurrent participation in another interventional trial
- Received empirical antibiotics for more than seven days from febrile neutropenic episode onset
- Septic shock at onset or within 72 hours defined by persistent hypotension requiring vasopressors and elevated lactate despite resuscitation
- Febrile neutropenia secondary to treatment for solid malignancies, autologous HSCT, CAR-T cell therapy, hematologic malignancies other than acute leukemia outside allogeneic HSCT context, AML consolidation chemotherapy, or ALL intensification/maintenance chemotherapy
- Clinically or microbiologically documented infections except treated probable or proven invasive fungal disease
- Receiving induction chemotherapy or allogeneic HSCT as outpatients
- Previously enrolled in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, depending on neutrophil recovery or early discontinuation after 72 hours
Participants receive antibiotic treatment for febrile neutropenia. Those in the early discontinuation group stop antibiotics after at least 72 hours of treatment and being afebrile for 24 hours, regardless of neutrophil count. Those in the prolonged treatment group continue antibiotics until neutropenia resolves.
Visits as needed during treatment period to monitor health and antibiotic use
Duration - 30 days from randomization
Participants are monitored for safety outcomes, including mortality, ICU transfer, infections, and other health events for 30 days after randomization.
Follow-up visits or assessments during the 30-day period
Trial Site Locations
Total: 4 locations
1
Alberta Health Services
Edmonton, Canada
Actively Recruiting
2
London Health Sciences Centre
London, Canada
Actively Recruiting
3
University Health Network
Toronto, Canada
Actively Recruiting
4
Vancouver General Hospital
Vancouver, Canada
Actively Recruiting
Research Team
S
Shahid Husain, MD
R
Roni Bitterman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here