Actively Recruiting
Short Antibiotic Treatment in High Risk Febrile Neutropenia
Led by University Health Network, Toronto · Updated on 2024-07-17
80
Participants Needed
4
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 undergoing allogeneic hematopoietic stem-cell transplantation with conditioning chemotherapy and/or radiation
- Documented febrile neutropenia defined by single oral temperature 38.36C or at least two measurements 38.06C within 1 hour and absolute neutrophil count (ANC) 0.5x10^9/L
- No clinically or microbiologically documented infection at baseline, including negative blood cultures and no infection focus on physical exam
- Received empirical antibiotics for at least 72 hours
- Afebrile for at least 24 hours
- Still neutropenic with ANC 0.5x10^9/L
You will not qualify if you...
- Currently participating in another interventional trial
- Received empirical antibiotics for more than seven days from the febrile neutropenic episode onset
- Septic shock at onset or within 72 hours, defined as persistent low blood pressure requiring vasopressors and elevated lactate despite treatment
- Febrile neutropenia due to treatment for solid tumors, autologous HSCT, CAR-T cell therapy, hematologic malignancies other than acute leukemia outside allogeneic HSCT context, or AML/ALL treated with consolidation, intensification, or maintenance chemotherapy
- Presence of clinically or microbiologically documented infections except for treated probable or proven invasive fungal disease
- Receiving induction chemotherapy or allogeneic HSCT as outpatient
- Previously enrolled in this study
AI-Screening
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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
CONTACT
R
Roni Bitterman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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