Phase III Study on Early Reduction of Antibiotics for Neutropenic Fever in Patients Undergoing Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating the safety and feasibility of stopping empirical antibiotics early in patients with neutropenic fever who are undergoing hematopoietic stem cell transplantation HSCT. This trial compares early de-escalation of antibiotics with standard treatment to see if patients can safely reduce antibiotic use. All participants have neutropenic fever and have been treated with empirical antibiotics including imipenem, and vancomycin if fever persists. Participants start with empirical antibiotics when fever develops during neutropenia. After being fever-free for 72 hours, patients are randomly assigned to one of two groups. In the early de-escalation group, empirical antibiotics are stopped and levofloxacin prophylaxis is resumed. The control group continues empirical antibiotics until neutropenia resolves or for at least 7 days. Levofloxacin is given regularly as prophylaxis during the transplantation process. During the study, researchers monitor the duration without empirical antibiotics over 28 days. Patients will be assessed for safety and feasibility of stopping antibiotics early. The study tracks fever status, blood counts, and infections. Participation lasts through the neutropenic fever episode and includes follow-up to measure outcomes. The trial is randomized with no masking and aims to gather data on antibiotic use in this setting.

Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever