E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
myelodysplastic syndrome or acute myeloid leukeamia |
|
E.1.1.1 | Medical condition in easily understood language |
haematological malignancies |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficiency of an antibioprophylaxy by levofloxacin on the occurrence of a febrile episode requiring a hospitalization and an antibiotherapy in patients treated by azacitidine |
|
E.2.2 | Secondary objectives of the trial |
-Determine the origin and the incidence of infectious events in the two arms
-overall survival at one year
-compare the incidence of apparition of multi-drug resistant bacteria between the two arms
-compare the duration of hospitalization for the febrile episode requiring hospitalization and introduction of an antibiotic by intravenous route between the two arms
-identify clinical and biological risk factors associated to the occurrence of these infectious events
-evaluate the safety profile of the levofloxacin
-compare the cause of death between the two arms
-evaluate the dose/intensity of Azacitidine
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal exclusion criteria |
-allergy to quinolone
-previous event of tenopathy due to quinolone
-participation to another therapeutic clinical trial |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Apparition of the first febrile episode during the 6 first cycles of azacitidine requiring a hospitalization and introduction of an antibiotic (with or without discontinuation of levofloxacin) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after the 6 first cycles of azacitidine |
|
E.5.2 | Secondary end point(s) |
-index the infectious agents responsible for the infectious events in the two arms
-rate of overall survival at one year
- apparition of multi-drug resistant bacteria
-Duration of hospitalization and number of days of antiobitic or antifongic treatment
-duration of antibioprophylaxy in experimental arm
-Apparition of an infection during the treatment by azacitidine and risk factors of azacitidine
-Toxicity will be compared between the two arms
-Causes of death will be compared between two arms
-dose of azacitidine received compared to maximal theoretical dose |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after the 6 first cycles of azacitidine and at one year |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial will occur when the last patient enrolled will have its last visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |