Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Phase 3

• Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia
• Interventions: Drug: Levofloxacin

• Registration Number: NCT03594149
• Lead Sponsor: 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).

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 Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-10
• Study Start: 2018-07-18
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-20
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24
• Primary Completion: 2021-10-11
• Study Completion: 2022-07-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antibacterial prophylaxis	Levofloxacin	Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine

Primary Outcome Measures

Name	Time	Method
Febrile episode occurrence	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

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

Trial Locations

Locations (4)

CHU Amiens; 🇫🇷 Amiens, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHU Caen; 🇫🇷 Caen, France

CHRU Lille; 🇫🇷 Lille, France