Clinical trial NCT03594149: Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients
Official title: Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Keywords: levofloxacin, antibacterial prophylaxis, febrile episode
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Febrile episode occurrence
timeFrame: 3 cycles of 28 days
Secondary outcomes:
measure: one-year overall survival rate
timeFrame: one year
measure: infectious agents documented in each arm
timeFrame: one year
measure: infectious events rate
timeFrame: one year
measure: apparition of multi-drug resistant bacteria
timeFrame: one year
measure: duration of hospitalization
timeFrame: one year
measure: carbapenem and glycopeptide consumption in both two arms
timeFrame: 3 years
measure: death causes
timeFrame: one year
measure: toxicity profile (adverse event)
timeFrame: one year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Caen
country: France
facility: CHU Caen
city: Lille
country: France
facility: CHRU Lille
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Stamatoullas-Bastard Aspasia, MD
role: PRINCIPAL_INVESTIGATOR
References: