A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Invasive Candidiasis
About this trial
This is an interventional treatment trial for Invasive Candidiasis
Eligibility Criteria
Inclusion Criteria: Clinical and Laboratory evidence of blood stream &/or systemic candida infections Exclusion Criteria: Possible candida contamination Candida colonization (non invasive infection), urine, cardiac, bone or brain and prosthetic device infections Acute or moderately severe liver disease Abnormal liver function tests Abnormal blood clotting for patients on blood thinners
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
50 mg intravenous (IV) infusion (diluted with 9% saline) administered daily (following a 70-mg IV loading dose on Day 1), over the course of ~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection.
150 mg intravenous (IV) infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection.