Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Overview

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).

Full Title of Study: “Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 11, 2021

Detailed Description

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.

Interventions

  • Drug: Levofloxacin
    • Levofloxacin 500 mg/d p.o.

Arms, Groups and Cohorts

  • Experimental: antibacterial prophylaxis
    • Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine
  • No Intervention: control
    • No levofloxacin will be given.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Henri Becquerel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stamatoullas-Bastard Aspasia, MD, Principal Investigator, Centre Henri Becquerel
  • Overall Contact(s)
    • Richard Doriane, phD, +33232082985, doriane.richard@chb.unicancer.fr

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