Efficiency of an antibioprophylaxy (levofloxacin) in patient treated by azacitidine

Efficiency of an antibioprophylaxy (levofloxacin) in patient treated by azacitidine - AZABAC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000445-51-FR

Enrollment

108

Registered

2018-04-18

Start date

2018-03-23

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelodysplastic syndrome or acute myeloid leukeamia

Interventions

Trade Name: LEVOFLOXACIN Product Name: levofloxacin Pharmaceutical Form: Tablet INN or Proposed INN: levofloxacine CAS Number: 138199-71-0 Other descriptive name: LEVOFLOXACIN HEMIHYDRATE Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age superior to 18 years old patients treated by azacitidine for their myelodysplastic syndrome or acute myeloid leukaemia ECOG inferior to 3 Life expectancy superior to 3 months signed inform consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54

Exclusion criteria

Exclusion criteria: -allergy to quinolone -previous event of tenopathy due to quinolone -participation to another therapeutic clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficiency of an antibioprophylaxy by levofloxacin on the occurrence of a febrile episode requiring a hospitalization and an antibiotherapy in patients treated by azacitidine;Secondary Objective: -Determine the origin and the incidence of infectious events in the two arms -overall survival at one year -compare the incidence of apparition of multi-drug resistant bacteria between the two arms -compare the duration of hospitalization for the febrile episode requiring hospitalization and introduction of an antibiotic by intravenous route between the two arms -identify clinical and biological risk factors associated to the occurrence of these infectious events -evaluate the safety profile of the levofloxacin -compare the cause of death between the two arms -evaluate the dose/intensity of Azacitidine ;Primary end point(s): Apparition of the first febrile episode during the 6 first cycles of azacitidine requiring a hospitalization and introduction of an antibiotic (with or without discontinuation of levofloxacin);Timepoint(s) of evaluation of this end point: after the 6 first cycles of azacitidine	—

Measure

Time frame

Main Objective: Evaluate the efficiency of an antibioprophylaxy by levofloxacin on the occurrence of a febrile episode requiring a hospitalization and an antibiotherapy in patients treated by azacitidine;Secondary Objective: -Determine the origin and the incidence of infectious events in the two arms -overall survival at one year -compare the incidence of apparition of multi-drug resistant bacteria between the two arms -compare the duration of hospitalization for the febrile episode requiring hospitalization and introduction of an antibiotic by intravenous route between the two arms -identify clinical and biological risk factors associated to the occurrence of these infectious events -evaluate the safety profile of the levofloxacin -compare the cause of death between the two arms -evaluate the dose/intensity of Azacitidine ;Primary end point(s): Apparition of the first febrile episode during the 6 first cycles of azacitidine requiring a hospitalization and introduction of an antibiotic (with or without discontinuation of levofloxacin);Timepoint(s) of evaluation of this end point: after the 6 first cycles of azacitidine

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Secondary

Measure	Time frame
Secondary end point(s): -index the infectious agents responsible for the infectious events in the two arms -rate of overall survival at one year - apparition of multi-drug resistant bacteria -Duration of hospitalization and number of days of antiobitic or antifongic treatment -duration of antibioprophylaxy in experimental arm -Apparition of an infection during the treatment by azacitidine and risk factors of azacitidine -Toxicity will be compared between the two arms -Causes of death will be compared between two arms -dose of azacitidine received compared to maximal theoretical dose ;Timepoint(s) of evaluation of this end point: after the 6 first cycles of azacitidine and at one year	—

Measure

Time frame

Secondary end point(s): -index the infectious agents responsible for the infectious events in the two arms -rate of overall survival at one year - apparition of multi-drug resistant bacteria -Duration of hospitalization and number of days of antiobitic or antifongic treatment -duration of antibioprophylaxy in experimental arm -Apparition of an infection during the treatment by azacitidine and risk factors of azacitidine -Toxicity will be compared between the two arms -Causes of death will be compared between two arms -dose of azacitidine received compared to maximal theoretical dose ;Timepoint(s) of evaluation of this end point: after the 6 first cycles of azacitidine and at one year

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Countries

France

Contacts

Public ContactCRA Manager

Centre Henri Becquerel

doriane.richard@chb.unicancer.fr+33232082985

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026