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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Levofloxacin 500 mg/d p.o.
CHU Amiens
Amiens, France
CHU Caen
Caen, France
CHRU Lille
Lille, France
Centre Henri Becquerel
Rouen, France
Febrile episode occurrence
Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation
Time frame: 3 cycles of 28 days
one-year overall survival rate
overall survival at one year in both two arms
Time frame: one year
infectious agents documented in each arm
index of infectious agents in both two arms
Time frame: one year
infectious events rate
number of infectious events in both two arms
Time frame: one year
apparition of multi-drug resistant bacteria
index of multi-drug resistant bacteria in both two arms
Time frame: one year
duration of hospitalization
number of days of hospitalization and number of days of antibiotic or antifungal treatment
Time frame: one year
carbapenem and glycopeptide consumption in both two arms
consumption of carbapenem and glycopeptide during inclusion period and comparison with the 3 previous years
Time frame: 3 years
death causes
index of death causes in each arms
Time frame: one year
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toxicity profile (adverse event)
toxicity will be established with description of adverse event in both two arms
Time frame: one year