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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00083343 |
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.
Condition | Intervention | Phase |
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Candidiasis |
Drug: MK0991, caspofungin acetate/Duration of Treatment: variable |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 50 |
Study Start Date: | August 2004 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_102, Formerly-0404NBCI, MK0991-045 |
Study First Received: | May 20, 2004 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00083343 |
Health Authority: | United States: Food and Drug Administration |
Mycoses Echinocandins Candidiasis Clotrimazole |
Miconazole Caspofungin Tioconazole Torulopsis |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Infection Pharmacologic Actions |