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. The investigators 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, the investigators will monitor both groups of patients to see if the investigators 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).
Age ≥ 18 years
Diagnosis of myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, or acute myeloid leukemia
Participant is deemed unlikely to survive >30 days (as determined by clinical team)
Participant unable to provide informed consent
Fever/infection within 1 month of chemotherapy initiation
C-difficile infection within 12 months of chemotherapy initiation
Parallel
Levofloxacin
DrugThis group will receive Levofloxacin 500mg orally daily over the 90-day trial period. Patients will take the levofloxacin daily regardless of their neutrophil count.
Usual Care
Other interventionThis group will receive usual care. Routine antibiotic prophylaxis is not permitted.
Patient enrollment feasibility
Our primary measure of feasibility will be the ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active).
Ability to consent 30% of eligible patients
The consent rate to be adequate if 30% of eligible patients are enrolled.
Protocol adherence
Protocol adherence to be acceptable provided that 80% of all intended medication doses per patient are administered
Off-protocol prophylaxis antibiotic use
Off-protocol prophylaxis antibiotic use acceptable if \<10% in the control arm
Outcome completion
Outcome completion is adequate if 90% of outcomes are completed
Frequency of febrile neutropenia
Measure and report the frequency of febrile neutropenia and calculate the mean and median number of febrile neutropenic events per patient.
Frequency of hospitalizations due to infection
Measure the frequency of hospitalizations due to infection and calculate the mean and median number of infection-related hospitalizations per patient.
Number of deaths due to infection
Record the number of deaths due to infection.
Frequency of chemotherapy delays
Measure the frequency of chemotherapy delays of ≥1 week. Calculate the mean and median number of ≥1-week chemotherapy cycle delays per patient.
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