Conditions: Leukopenia
Keywords: high-risk leukopenic patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 252
Healthy volunteers: no

Brief summary:
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

Detailed description:

Arms:
arm 1: Posaconazole oral suspension 200 mg three times a day (TID) arm 2: Fluconazole 400 mg once daily (QD)

Interventions: intervention 1: Posaconazole intervention 2: Fluconazole
Intervention descriptions: intervention 1: 40 mg/mL; 200 mg (5 mL) TID

Treatment was continued with each cycle of chemotherapy until:

* The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
* 3 chemotherapy cycles or
* Total treatment duration up to 12 weeks (84 days) intervention 2: 50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules);

400 mg QD

Treatment was continued with each cycle of chemotherapy until:

* The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
* 3 chemotherapy cycles or
* Total treatment duration up to 12 weeks (84 days)

Protocol document: