Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Acute Myeloid Leukemia Clinical Trial

— AZABAC  

Official title:

Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594149
• Other study ID #: CHB 17.01
• Status: Recruiting
• Phase: Phase 3
• Start date: July 18, 2018
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2018
• Source: Centre Henri Becquerel
• Contact: Richard Doriane, phD
• Phone: +33232082985
• Email: doriane.richard[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 11, 2022
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Levofloxacin
Levofloxacin 500 mg/d p.o.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Caen	Caen
France	CHRU Lille	Lille
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

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