Overview

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)

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
0
Participant gender:
All
Summary
Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Antifungal Agents
Caspofungin
Echinocandins
Miconazole
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