Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
After day 7 from randomization until day 30
No
Mical Paul, MD
Principal Investigator
Rabin Medical Center
Israel: Ministry of Health
RabinMC6249
NCT01450241
January 2012
January 2015
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