The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.
Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
Continued antibiotic treatment as accepted by guidelines for febrile neutropenia
Rabin Medical Center, Beilinson Hospital
Petah Tikvah, Israel
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (\>=3 daily for \>=2 days) or fever (\>38)
Time frame: After day 7 from randomization until day 30
Total febrile or antibiotic days
Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement \>38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis
Time frame: From the day of randomization until day 30
Clinically and/or microbiologically documented infections
Clinically and/or microbiologically documented infections within 30 days of randomization. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections (including Clostridium difficile) and the 2008 revised definitions for invasive fungal infections.
Time frame: 30 days
Total in-hospital days
Total in-hospital days from the day of randomization up to day 30
Time frame: 30 days
Re-admission
Rates of re-admission for any reason other than planned chemotherapy.
Time frame: 30 days
Antibiotic treatment
Patients receiving antibiotic treatment after day 7 from randomization until day 30
Time frame: After day 7 from randomization until day 30
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Antifungal treatment
Institution of antifungal treatment
Time frame: 30 days
Duration of intravenous antibiotic treatment
Duration of intravenous antibiotic treatment
Time frame: 30 days
Duration of neutropenia
Duration of neutropenia
Time frame: 30 days
Development of resistance
Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.
Time frame: 30 days
All-cause mortality
All-cause mortality
Time frame: 30 days
Infection-related mortality
Cause of death adjudicated by the trial's safety committee
Time frame: 30 days after randomization