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

NCT07528417 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-22

No results posted yet for this study

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. 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).

Conditions

Interventions

DRUG

Levofloxacin

This group will receive Levofloxacin 500mg orally daily over the 90-day trial period. Patients will take the levofloxacin daily regardless of their neutrophil count.

OTHER

Usual Care

This group will receive usual care. Routine antibiotic prophylaxis is not permitted.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528417 on ClinicalTrials.gov