Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

Conditions
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Myelodysplastic Syndromes, Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antibacterial prophylaxis<br>Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine | Drug: Levofloxacin<br>* Levofloxacin 500 mg/d p.o.<br>* Other names: LVF;|
| No Intervention: control<br>No levofloxacin will be given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile episode occurrence | Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation | 3 cycles of 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-year overall survival rate | overall survival at one year in both two arms | one year | 
| infectious agents documented in each arm | index of infectious agents in both two arms | one year | 
| infectious events rate | number of infectious events in both two arms | one year | 
| apparition of multi-drug resistant bacteria | index of multi-drug resistant bacteria in both two arms | one year | 
| duration of hospitalization | number of days of hospitalization and number of days of antibiotic or antifungal treatment | 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 | 3 years | 
| death causes | index of death causes in each arms | one year | 
| toxicity profile (adverse event) | toxicity will be established with description of adverse event in both two arms | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levofloxacin, antibacterial prophylaxis, febrile episode