The goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever. The main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'SAFE study'. Participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. An additional blood sample, urine sample and stool sample will be collected. Researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
410
This study compares two management strategies of patients undergoing treatment with chemotherapy or a stem cell transplantation. One strategy is to treat these patients at the time of febrile neutropenia with a fixed 72 hours course of EBAT. The other, more commonly followed strategy is a longer minimum EBAT duration of 5 days as well as other variables like neutrophil recovery and defervescence. In both arms, definitive treatment is given when an infectious cause of the fever is found according to local guidelines (e.g. pneumonia or mucosits with bacteremia).
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGAbsence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy.
Time frame: 42 days
Incidence of bacteraemia within 42 days after randomisation
Time frame: 42 days
Clinically documented infections
Time frame: 42 days
Number of documented bacterial infections
Time frame: 42 days
Total days of non-prophylactic antibiotics given to the patient at engraftment
Time frame: 42 days
Total numbers of antibiotic switches before neutrophil recovery
Time frame: 42 days
Incidence of Clostridium difficile infection
Time frame: 42 days
Incidence, severity and duration of diarrhea
Time frame: 42 days
Incidence of candidemia
Time frame: 42 days
Length of hospital stay in the first 42 days after randomization
Time frame: 42 days
Number of patients admitted to the ICU within 42 days after randomisation
Time frame: 42 days
Number of readmissions within 42 days
Time frame: 42 days
Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE
Time frame: 42 days
Duration of hospitalization
Time frame: 42 days
Number of patients in the short treatment arm with ongoing fever at time of EBAT stop
Time frame: 42 days
Incidence of acute GVHD (grade II or higher) in the transplanted study population
Time frame: 42 days
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