Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2024-12-29

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).

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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.

Conditions

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Myelodysplastic Syndromes Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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antibacterial prophylaxis

Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

Levofloxacin 500 mg/d p.o.

control

No levofloxacin will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levofloxacin

Levofloxacin 500 mg/d p.o.

Intervention Type DRUG

Other Intervention Names

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LVF

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No