A Randomized Controlled Trial of Posaconazole (SCH 56592) Vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients
- Adults or adolescents (age>13 years) and weight> 34kg, either gender
- Disease definition: Anticipated or documented prolonged neutropenia (ANC<500/mm3 2)
Eastern Cooperative Oncology Group (ECOG) performance score of less than 3.
- Female subjects of childbearing age must be using a medically accepted method of
birth control before beginning study-drug treatment and agree to continue its use
during the study or be surgically sterilized (eg, hysterectomy or tubal ligation).
- Female subjects of childbearing potential must have a negative serum pregnancy test
(beta-hcG) at Baseline or within 72 hours before the start of the study drug.
- Female subjects who are pregnant, intend to become pregnant, or are nursing.
- Excluded prior treatments: Subjects previously treated with AMB, FLZ, or ITZ for
proven or probable IFI within 30 days of enrollment.
- Excluded treatments prior to specific study phases: Subjects who have taken the
following drugs: those known to interact with azoles and that may lead to
life-threatening side effects.
- Subjects who have used any investigational drugs or biologic agents other than their
chemotherapy regimens within 30 days of study entry.
- Subjects who are participating in any other blinded clinical study within 30 days of
- Subjects with renal insufficiency (estimated creatinine clearance less than 20
mL/minute at Baseline or likely to require dialysis during the study).
- Subjects having an ECG with a prolonged QTc interval by manual reading: QTc greater
than 450 msec for men and greater than 470 msec for women.
- Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate
aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase
levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin
level greater than 3 times the ULN.