Antifungal prophylaxis in patients with acute myeloid leukemia
Conditions
Brief summary
The cumulative incidence of proven and probable invasive fungal infections, invasive mold infections and invasive aspergillosis (IMI) at 180 days is defined as the proportion of patients who experienced proven and probable IMI within 180 days from the first dose of antifungal prophylaxis treatment after randomization.
Detailed description
The cumulative incidence of possible IMI by day 180 in the ITT population., The cumulative incidence of probable and proven IFI, namely: (a) all IFI, (b) IA only and (c) IC only in the ITT patient population by day 180, The time to probable and proven IMI during 180 days in the ITT population., The overall survival in the ITT population by day 180., The time to first use and the number of patient-days of amphotericin B or an echinocandin in the ITT population during 180 days., The frequency and distribution of adverse events (AE) of interest in posaconazole and fluconazole treated participants in the ITT population during 180 days, namely (a) elevation of liver tests and (b) prolongation of QTc interval on ECG., The cumulative incidence of probable and proven IFI, namely: all IFI, all IMI, IA only and IC only in the per protocol (PP) population by day 180.
Interventions
DRUGDiflucan 50 mg Hartkapseln
DRUGPOSACONAZOLE VIATRIS 40 mg/mL
DRUGFLUCONAZOLE ARROW 50 mg
DRUGgélule
DRUGPOSACONAZOLE ZENTIVA 100 mg
DRUGFLUCONAZOLE ARROW 200 mg
DRUGDiflucan 2 mg/ml Infusionslösung
DRUGFLUCONAZOLE KABI 2 mg/ml
DRUGsolution pour perfusion.
Sponsors
Centre Hospitalier Universitaire Vaudois
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence of proven and probable invasive fungal infections, invasive mold infections and invasive aspergillosis (IMI) at 180 days is defined as the proportion of patients who experienced proven and probable IMI within 180 days from the first dose of antifungal prophylaxis treatment after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative incidence of possible IMI by day 180 in the ITT population., The cumulative incidence of probable and proven IFI, namely: (a) all IFI, (b) IA only and (c) IC only in the ITT patient population by day 180, The time to probable and proven IMI during 180 days in the ITT population., The overall survival in the ITT population by day 180., The time to first use and the number of patient-days of amphotericin B or an echinocandin in the ITT population during 180 days., The frequency and distribution of adverse events (AE) of interest in posaconazole and fluconazole treated participants in the ITT population during 180 days, namely (a) elevation of liver tests and (b) prolongation of QTc interval on ECG., The cumulative incidence of probable and proven IFI, namely: all IFI, all IMI, IA only and IC only in the per protocol (PP) population by day 180. | — |
Countries
Belgium, France
Outcome results
None listed