Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

• Status: Recruiting
• Trial end date: 2022-07-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Henri Becquerel
• Treatments: Anti-Bacterial Agents; Azacitidine; Levofloxacin; Ofloxacin

Criteria

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