A randomized, open label parallel controlled, multicenter study to evaluate safety and
efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic
patients for prevention of invasive fungal infection
Inclusion Criteria:
- Subjects must be 18-70 years of age of either sex;
- Persistent neutropenia (ANC < 500/mm3 [0. 5x109/L]）or, probable neutropenia in 3-5
days is anticipated. Neutropenia caused by the following reasons prolongs >=7days.
- Standard or dose-intense chemotherapy, anthracyclines or other acceptable
chemotherapies ( any investigational drug is not permitted) for AML treatment
- Retreatment of chemotherapy in case of AML recurrence
- MDS shifts to AML and bone marrow arrest induction chemotherapy is required (
not including acute phase of CML)
- Informed consent obtained from subject or legal guardian
Exclusion Criteria:
- Subjects previously treated with AMB, FLZ, or ITZ within 30 days of enrollment.
- Subjects who have taken the following drugs:
- terfenadine, cisapride, and ebastine within 24 hours before entry
- astemizole at entry or within 10 days before entry
- cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates,
isoniazid atharanthine and anthracyclines within 24 hours before entry
- The above drugs are refrained during the investigation
- Serious organ deseases except hematological disorder such as cardiac or neurologic
disorders or impairment expected to be unstable or progressive during the course of
this study (eg, seizures or demyelinating syndromes, acute myocardial infarction
within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial
fibrillation with ventricular rate <60/min, or history of torsades de pointes,
symptomatic ventricular or sustained arrhythmias), unstable electrolyte
abnormalities.
- Subjects who have used any investigational drugs or biologic agents other than their
chemotherapy regimens within 30 days of study entry.
- Prior enrollment in this study.
- Subjects with known or suspected hypersensitivity or idiosyncratic reaction to azole
agents or amphotericin B.
- Subjects with known or suspected IFI at screen
- Subjects with severe renal insufficiency (estimated creatinine clearance less than 50
mL/minute or likely to require dialysis during the study), ALT,AST AKP or total
bilirubin are >2×ULN.
- Subjects having an ECG with a prolonged QTc interval: QTc greater than 450 msec for
men and greater than 470 msec for women.
- Subjects with AML or CML history.
- Subjects with a history of allogeneic hematopoietic stem cell, bone marrow
transplantation, autologous stem cell transplantation history.
- Female subjects who are pregnant or are nursing.
- Alcohol and/or drug abuse.
- Subjects cannot be compliant in the opinion of the investigator.
