Efficiency of an antibioprophylaxy (levofloxacin) in patient treated by azacitidine
Phase 1
- Conditions
- myelodysplastic syndrome or acute myeloid leukeamiaTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2017-000445-51-FR
- Lead Sponsor
- Centre Henri Becquerel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
Age superior to 18 years old
patients treated by azacitidine for their myelodysplastic syndrome or acute myeloid leukaemia
ECOG inferior to 3
Life expectancy superior to 3 months
signed inform consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
Exclusion Criteria
-allergy to quinolone
-previous event of tenopathy due to quinolone
-participation to another therapeutic clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method