Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia

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.

NCT Number	NCT05926063
Lead Sponsor	Universitaire Ziekenhuizen KU Leuven Collaborators: University Hospital, Ghent, Universitair Ziekenhuis Brussel, University Hospital, Antwerp, AZ Sint-Jan AV, Centre Hospitalier Universitaire de Liege, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions	Neutropenia, Febrile
Enrollment	410 participants
Start Date	2024-02-26
Primary Completion	2026-07 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2024-03-08