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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibacterial prophylaxis | Experimental | Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine |
|
| control | No Intervention | No levofloxacin will be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | Levofloxacin 500 mg/d p.o. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stamatoullas-Bastard Aspasia, MD | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80000 | France | |||
| CHU Caen |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| 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 |
| Caen |
| 14033 |
| France |
| CHRU Lille | Lille | 59037 | France |
| Centre Henri Becquerel | Rouen | 76000 | France |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |