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Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients (AZABAC)

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ClinicalTrials.gov Identifier: NCT03594149
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

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).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Acute Myeloid Leukemia Drug: Levofloxacin Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : October 11, 2021
Estimated Study Completion Date : July 11, 2022


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 Name: LVF

No Intervention: control
No levofloxacin will be given.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594149


Contacts
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Contact: Richard Doriane, phD +33232082985 doriane.richard@chb.unicancer.fr

Locations
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France
CHU Amiens Not yet recruiting
Amiens, France, 80000
Contact: Gruson Berangere, Md         
Principal Investigator: Gruson Berangere, Md         
CHU Caen Not yet recruiting
Caen, France, 14033
Contact: Cheze Stephane, Md         
Principal Investigator: Cheze Stephane, Md         
CHRU Lille Not yet recruiting
Lille, France, 59037
Contact: Berthon Celine, Md         
Principal Investigator: Berthon Céline, MD         
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Richard Doriane, PhD    +33232082985    doriane.richard@chb.unicancer.fr   
Principal Investigator: Stamatoullas-Bastard Aspasia, MD         
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Stamatoullas-Bastard Aspasia, MD Centre Henri Becquerel

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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT03594149     History of Changes
Other Study ID Numbers: CHB 17.01
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Henri Becquerel:
levofloxacin, antibacterial prophylaxis, febrile episode
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Levofloxacin
Ofloxacin
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors