There is one clinical trial.
This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.
Methods: Eligible patients will be tested by competitive allele-specific Polymerase Chain Reaction (PCR) from blood-extracted DNA samples for the presence of PTX3 SNPs rs230561 and rs3816527.
Description: The cumulative incidence of proven and probable invasive mold infection (IMI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) in the intention-to-treat (ITT) population by day 180.
Measure: Cumulative incidence of proven and probable invasive mold infection (IMI) Time: Day 180Description: The cumulative incidence of possible invasive mold infection (IMI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) by day 180 in the ITT population.
Measure: Cumulative incidence of possible invasive mold infection (IMI) Time: Day 180Description: The cumulative incidence of probable and proven Invasive Fungal Infections (IFI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms), namely: (a) all IFI, (b) Invasive Aspergillosis (IA) only and (c) Invasive Candidiasis (IC) only in the ITT patient population by day 180.
Measure: Cumulative incidence of probable and proven Invasive Fungal Infections (IFI) Time: Day 180Description: The time to probable and proven invasive mold infection (IMI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) during 180 days in the ITT population
Measure: Time to probable and proven invasive mold infection (IMI) Time: Day 180Description: The overall survival in the ITT population by day 180.
Measure: Overall survival in the ITT population Time: Day 180Description: The time to use of amphotericin B/echinocandin in the ITT population during 180 days.
Measure: Time to use of amphotericin B/echinocandin Time: Day 180Description: The number of patient-days of amphotericin B/echinocandin in the ITT population during 180 days.
Measure: Number of patient-days of amphotericin B/echinocandin Time: Day 180Description: The frequency/distribution of AE of interest in posaconazole and fluconazole treated participants in the ITT population during 180 days, namely: Hepatotoxicity, defined by elevation of at least one of the following markers above >5x upper limit of normal: transaminases, alkaline phosphatase and/or above >3x upper limit of normal total bilirubin New QTc prolongation, defined as QTc >450 msec for men and >470 msec for women
Measure: Frequency/distribution of adverse events (AE) of interest Time: Day 180Description: The cumulative incidence of probable and proven invasive fungal infections (IFI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) , namely: all Invasive Fungal Infections (IFI), all Invasive Mold Infections (IMI), Invasive Aspergillosis (IA) only and Invasive Candidiasis (IC) only in the per protocol (PP) population by day 180.
Measure: Cumulative incidence of probable and proven invasive fungal infections (IFI) in per protocol population Time: Day 180