Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients (AZABAC)

Efficiency of Antibacterial Prophylaxis (Levofloxacin) 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).

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Intervention / Treatment: Drug: Levofloxacin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: RICHARD DORIANE, PhD; Phone Number: +33232082985; Email: doriane.richard@chb.unicancer.fr

Study Locations

• France
  • Amiens, France, 80000
    • Not yet recruiting
    • CHU Amiens
    • Contact: Gruson Berangere, Md
    • Principal Investigator: Gruson Berangere, Md
  • Caen, France, 14033
    • Not yet recruiting
    • CHU Caen
    • Contact: Cheze Stephane, Md
    • Principal Investigator: Cheze Stephane, Md
  • Lille, France, 59037
    • Not yet recruiting
    • CHRU Lille
    • Contact: Berthon Celine, Md
    • Principal Investigator: Berthon Céline, MD
  • Rouen, France, 76000
    • Recruiting
    • Centre Henri Becquerel
    • Contact: RICHARD DORIANE, PhD; Phone Number: +33232082985; Email: doriane.richard@chb.unicancer.fr
    • Principal Investigator: Stamatoullas-Bastard Aspasia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: antibacterial prophylaxis; Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine	Drug: Levofloxacin; Levofloxacin 500 mg/d p.o.; Other Names: LVF
No Intervention: control; No levofloxacin will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Stamatoullas-Bastard Aspasia, MD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Anticipated): October 11, 2021
• Study Completion (Anticipated): July 11, 2022

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: levofloxacin, antibacterial prophylaxis, febrile episode
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myelodysplastic Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: CHB 17.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No