Clinical Research Directory

Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)

Sponsor: University of Manitoba

Summary

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life-changing blood cancers. Patients with MDS and AML commonly experience complications related to infection, which affect patient quality-of-life and can sometimes lead to hospitalization or death. We will conduct a randomized controlled trial to evaluate the effectiveness and safety of levofloxacin (antibiotic) in MDS and AML patients to safely reduce the risk of infection. In this study 50% of patients will be randomized (like a flip of a coin) to receive levofloxacin and the other 50% will receive usual care (control). The primary objective of the trial is to demonstrate the feasibility of a pragmatic pilot trial necessary to inform our planned phase 3 trial. Additionally, we will monitor both groups of patients to see if we improve the risk and/or severity of infection. Levofloxacin is commonly used in other clinical settings but has not been studied in patients with MDS or AML receiving outpatient chemotherapy (ie, chemotherapy that can be given from clinic, rather than a hospital).

Official title: Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial

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