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NCT Number: NCT03594149

Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

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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Key information

Conditions

Myelodysplastic Syndromes Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin

Drug

Levofloxacin 500 mg/d p.o.

Other names: LVF

Primary outcomes

  1. Febrile episode occurrence

    Time frame: 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 outcomes

  1. one-year overall survival rate

    Time frame: one year

    overall survival at one year in both two arms

  2. infectious agents documented in each arm

    Time frame: one year

    index of infectious agents in both two arms

  3. infectious events rate

    Time frame: one year

    number of infectious events in both two arms

  4. apparition of multi-drug resistant bacteria

    Time frame: one year

    index of multi-drug resistant bacteria in both two arms

  5. duration of hospitalization

    Time frame: one year

    number of days of hospitalization and number of days of antibiotic or antifungal treatment

  6. carbapenem and glycopeptide consumption in both two arms

    Time frame: 3 years

    consumption of carbapenem and glycopeptide during inclusion period and comparison with the 3 previous years

  7. death causes

    Time frame: one year

    index of death causes in each arms

  8. toxicity profile (adverse event)

    Time frame: one year

    toxicity will be established with description of adverse event in both two arms

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

Acronym: AZABAC

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2018
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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