Conditions: Aspergillosis
Keywords: invasive aspergillosis, opportunistic mold infection
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

Detailed description:
The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Arms:
arm 1: anidulafungin plus voriconazole arm 2: anidulafungin plus voriconazole

Interventions: intervention 1: voriconazole intervention 2: anidulafungin
Intervention descriptions: intervention 1: Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance \<50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). intervention 2: Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy

Protocol document: