Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
levofloxacin, antibacterial prophylaxis, febrile episode
Brief 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).
Detailed description
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.
Interventions
DRUGLevofloxacin
Levofloxacin 500 mg/d p.o.
Sponsors
Centre Henri Becquerel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Febrile episode occurrence | 3 cycles of 28 days | Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| infectious agents documented in each arm | one year | index of infectious agents in both two arms |
| infectious events rate | one year | number of infectious events in both two arms |
| apparition of multi-drug resistant bacteria | one year | index of multi-drug resistant bacteria in both two arms |
| one-year overall survival rate | one year | overall survival at one year in both two arms |
| carbapenem and glycopeptide consumption in both two arms | 3 years | consumption of carbapenem and glycopeptide during inclusion period and comparison with the 3 previous years |
| death causes | one year | index of death causes in each arms |
| toxicity profile (adverse event) | one year | toxicity will be established with description of adverse event in both two arms |
| duration of hospitalization | one year | number of days of hospitalization and number of days of antibiotic or antifungal treatment |
Countries
France
Outcome results
None listed