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Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients (AZABAC)

Primary Purpose

Myelodysplastic Syndromes, Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myelodysplastic Syndromes focused on measuring levofloxacin, antibacterial prophylaxis, febrile episode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • CHU Caen
  • CHRU Lille
  • Centre Henri BecquerelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

antibacterial prophylaxis

control

Arm Description

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

No levofloxacin will be given.

Outcomes

Primary Outcome Measures

Febrile episode occurrence
Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation

Secondary Outcome Measures

one-year overall survival rate
overall survival at one year in both two arms
infectious agents documented in each arm
index of infectious agents in both two arms
infectious events rate
number of infectious events in both two arms
apparition of multi-drug resistant bacteria
index of multi-drug resistant bacteria in both two arms
duration of hospitalization
number of days of hospitalization and number of days of antibiotic or antifungal treatment
carbapenem and glycopeptide consumption in both two arms
consumption of carbapenem and glycopeptide during inclusion period and comparison with the 3 previous years
death causes
index of death causes in each arms
toxicity profile (adverse event)
toxicity will be established with description of adverse event in both two arms

Full Information

First Posted
July 10, 2018
Last Updated
July 20, 2018
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT03594149
Brief Title
Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients
Acronym
AZABAC
Official Title
Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
October 11, 2021 (Anticipated)
Study Completion Date
July 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Keywords
levofloxacin, antibacterial prophylaxis, febrile episode

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antibacterial prophylaxis
Arm Type
Experimental
Arm Description
Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine
Arm Title
control
Arm Type
No Intervention
Arm Description
No levofloxacin will be given.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
LVF
Intervention Description
Levofloxacin 500 mg/d p.o.
Primary Outcome Measure Information:
Title
Febrile episode occurrence
Description
Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation
Time Frame
3 cycles of 28 days
Secondary Outcome Measure Information:
Title
one-year overall survival rate
Description
overall survival at one year in both two arms
Time Frame
one year
Title
infectious agents documented in each arm
Description
index of infectious agents in both two arms
Time Frame
one year
Title
infectious events rate
Description
number of infectious events in both two arms
Time Frame
one year
Title
apparition of multi-drug resistant bacteria
Description
index of multi-drug resistant bacteria in both two arms
Time Frame
one year
Title
duration of hospitalization
Description
number of days of hospitalization and number of days of antibiotic or antifungal treatment
Time Frame
one year
Title
carbapenem and glycopeptide consumption in both two arms
Description
consumption of carbapenem and glycopeptide during inclusion period and comparison with the 3 previous years
Time Frame
3 years
Title
death causes
Description
index of death causes in each arms
Time Frame
one year
Title
toxicity profile (adverse event)
Description
toxicity will be established with description of adverse event in both two arms
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Doriane, phD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stamatoullas-Bastard Aspasia, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gruson Berangere, Md
First Name & Middle Initial & Last Name & Degree
Gruson Berangere, Md
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheze Stephane, Md
First Name & Middle Initial & Last Name & Degree
Cheze Stephane, Md
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berthon Celine, Md
First Name & Middle Initial & Last Name & Degree
Berthon Céline, MD
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Doriane, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Stamatoullas-Bastard Aspasia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

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