SAFE study: Stopping Antibiotics after 3 days for the treatment of FEbrile Neutropenia in Haematology patients, a randomized open-label non-inferiority trial

Conditions

Febrile neutropenia

Brief summary

Absence 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.

Detailed description

Incidence of bacteraemia within 42 days after randomisation, Clinically documented infections, Number of documented bacterial infections, Total days of non-prophylactic antibiotics given to the patient at engraftment, Total numbers of antibiotic switches before neutrophil recovery, Incidence of Clostridium difficile infection, Incidence, severity and duration of diarrhea, Incidence of candidemia, Length of hospital stay in the first 42 days after randomization, Number of patients admitted to the ICU within 42 days after randomisation, Number of readmissions within 42 days, Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE, Duration of hospitalization, Number of patients in the short treatment arm with ongoing fever at time of EBAT stop, Incidence of acute GVHD (grade II or higher) in the transplanted study population

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGIMIPENEM

DRUGMEROPENEM

DRUGCEFEPIME

DRUGCEFTAZIDIME

DRUGPIPERACILLIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absence 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.	—

Secondary

Measure	Time frame
Incidence of bacteraemia within 42 days after randomisation, Clinically documented infections, Number of documented bacterial infections, Total days of non-prophylactic antibiotics given to the patient at engraftment, Total numbers of antibiotic switches before neutrophil recovery, Incidence of Clostridium difficile infection, Incidence, severity and duration of diarrhea, Incidence of candidemia, Length of hospital stay in the first 42 days after randomization, Number of patients admitted to the ICU within 42 days after randomisation, Number of readmissions within 42 days, Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE, Duration of hospitalization, Number of patients in the short treatment arm with ongoing fever at time of EBAT stop, Incidence of acute GVHD (grade II or higher) in the transplanted study population	—

Measure

Time frame

Incidence of bacteraemia within 42 days after randomisation, Clinically documented infections, Number of documented bacterial infections, Total days of non-prophylactic antibiotics given to the patient at engraftment, Total numbers of antibiotic switches before neutrophil recovery, Incidence of Clostridium difficile infection, Incidence, severity and duration of diarrhea, Incidence of candidemia, Length of hospital stay in the first 42 days after randomization, Number of patients admitted to the ICU within 42 days after randomisation, Number of readmissions within 42 days, Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE, Duration of hospitalization, Number of patients in the short treatment arm with ongoing fever at time of EBAT stop, Incidence of acute GVHD (grade II or higher) in the transplanted study population

—

Countries

Belgium

Outcome results

None listed