Levofloxacin to Prevent Infections in Outpatients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Tests levofloxacin against usual care to prevent infection in adults with these blood cancers.
Plain-language title generated from the registry record
Registry title: Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)
Key facts
- Where
- Winnipeg, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- CancerCare ManitobaWinnipeg, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Manitoba
- Trial code
- NCT07528417
- Record updated
- 29 June 2026
- Original description
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).Read full original descriptionShow less
Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial
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).
Inclusion: Master platform inclusion criteria:; Age ≥ 18 years; Diagnosis of myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, or acute myeloid leukemia; MYELO-CAN ABX inclusion criteria:; Initiation of hypomethylating agent-based chemotherapy.
Exclusion: Fever/infection within 1 month of chemotherapy initiation; C-difficile infection within 12 months of chemotherapy initiation; Known sensitivity/allergy to fluoroquinolones; History of tendon disorders related to fluoroquinolone administration; Seizure disorder; Master platform exclusion criteria:; Participant is deemed unlikely to survive >30 days (as determined by clinical team); Participant unable to provide informed consent; MYELO-CAN ABX exclusion criteria:; Myasthenia gravis; Pregnancy and/or breastfeeding.