Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

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).

This is a randomized prospective study with 2 arms to evaluate the efficacy of Levofloxacin prophylaxis in Azacytidine treated patients (MDS and AML) Levofloxacin will be given 500mg/d p.o. for the first three cycles of Azacytidine in patients randomized in arm antibacterial prophylaxis. In control arm patients will not received levofloxacin.

The expected duration of subject participation is one year after randomization.

Inclusion Criteria:

• Age superior to 18 years old
• SMD or AML treated with azacytidine (not previously treated)
• Life expectancy more than 3 months
• Performance status inferior to 3
• signed inform consent

Exclusion Criteria:

• allergy to quinolone
• previous event of tendopathy due to quinolone
• previous epileptic event
• systemic antibacterial prophylaxis the month before enrolment
• HIV positive
• bacterious infection of indetermined fever
• participation to an investigational drug trial
• Abnormalities in hepatic assessment
• QTc superior to 450 ms
• Pregnant or lactating women
• Myasthenia
• G6PD deficient
• severe and uncontrolled diabetes
• patient not able to understand trial