drugset / Trial / NCT03594149

Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

NCT03594149

Phase 3 Completed 60 enrolled Centre Henri Becquerel
RandomizedParallel-groupOpen-labelPrevention

Summary

Infections are a major life-threatening complication in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Currently there is no guidelines about antibacterial prophylaxis to prevent infections in patients with myelodysplastic syndrome or acute myeloid leukaemia. The investigators will conduct a randomized prospective study to evaluate the benefit of prophylactic antibacterial by levofloxacin on febrile episode in Azacytidine treated patients (MDS and AML).

Timeline

Start
2018-07-18
Primary completion
2024-07-17
Completion
2024-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Levofloxacin Small molecule 500 mg Oral