Outcomes {12}
death, fever, febrile neutropenia, infections, infection, Fever
HAND INFECTION, FEBRILE NEUTROPENIA, ADVERSE EVENTS, INFECTIONS, MIXED INFECTION, INFECTION
The primary endpoint is febrile neutropenia requiring antibacterial treatment.Fever is defined as a single oral temperature of 38.3 °C or a temperature of 38 °C sustained over a 1-h period.If the patient is receiving any medication highly likely to induce fever or has previously received a transfusion, at least one positive culture or infectious focus will be required for fever to be attributed to infection.When febrile neutropenia occurs and infection is suspected, prophylactic antibiotics will be discontinued and evaluation and therapy will be administered according to standard and local guidelines.Secondary endpoints are as follows:Documented infections. They will be classified according to Han’s criteria in one of these categories: microbiologically documented infection (bacterial viral or fungal), mixed infection, clinically documented infection, and possible infection (fever of unknown origin).The amount of concomitant antibiotics prescribed in addition to prophylactic drugs will be measured as a ratio of antibiotic days per days of hospitalization. Antibiotics will be classified according to the watch/reserve classification (21).Overall survival will be defined as the time from the day of randomization to the date of death (whatever the cause of death) or to the completion of the study. Fever-free survival will also be determined.Safety will be assessed by the incidence, severity and type of adverse events (AEs), and by the microbiological assessments: