Stopping Antibiotics After 3 Days for the Treatment of FEbrile Neutropenia in Haematology Patients (SAFE Study): a Randomized Open-label Non-inferiority Trial
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.
• 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.