SAFEStopping Antibiotics After 3 Days for the Treatment of FEbrile Neutropenia in Haematology Patients (SAFE Study): a Randomized Open-label Non-inferiority Trial
Comparison short vs extended EBAT treatment group
Cytopenia+9
+ Agranulocytosis
+ Hematologic Diseases
Supportive Care Study
Summary
Study start date: February 26, 2024
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.410 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; * Age older than 16 years; * Intensive therapy is started within three days before randomization for one of the following haematological conditions: * Remission induction chemotherapy for newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); OR * Re-induction chemotherapy for relapsed after haematological remission lasting for a minimum duration of 6 months; OR * Conditioning regimen to prepare for an allogeneic HCT; OR * Conditioning regimen to prepare for an autologous HCT. * Expected longstanding (≥ 7 days) neutropenia (ANC \< 0.5x10\^9/L); * Expected length of hospital stay of at least 10 days. Exclusion Criteria: 1. Clinically or microbiologically documented infection; 2. Patient already receives broad spectrum antibiotic therapy; 3. Any critical illness for which Intensive Care Unit treatment is required; 4. SOFA score ≥ 11; 5. Longstanding neutropenia (\>21 days) prior inclusion; 6. Previous enrolment in this study; 7. Not able to provide written informed consent; 8. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol; 9. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location