NCT00083343

Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)

A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults With Invasive Candida Infections (Excluding Patients With Candidemia as the Sole Site of Infection)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.

Conditions

• Candidiasis

Interventions

Type	Name	Description
DRUG	MK0991, caspofungin acetate/Duration of Treatment: variable

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2004-05-24
• Last updated: 2017-02-23