Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

NCT03594149 | Completed Phase 3 DMC

• 1 other identifier: CHB 17.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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).

Conditions

Myelodysplastic Syndromes; Acute Myeloid Leukemia

Keywords

levofloxacin, antibacterial prophylaxis, febrile episode

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• one-year overall survival rate

  one year

• infectious agents documented in each arm

  one year

• infectious events rate

  one year

• apparition of multi-drug resistant bacteria

  one year

• duration of hospitalization

  one year

Study Arms (2)

antibacterial prophylaxis

EXPERIMENTAL

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

Drug: Levofloxacin

control

NO INTERVENTION

No levofloxacin will be given.

Interventions

Levofloxacin DRUG

Levofloxacin 500 mg/d p.o.

Also known as: LVF

antibacterial prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (4)

CHU Amiens

Amiens, 80000, France

Location

CHU Caen

Caen, 14033, France

Location

CHRU Lille

Lille, 59037, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stamatoullas-Bastard Aspasia, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: July 18, 2018
• Primary Completion: July 17, 2024
• Study Completion: December 29, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)