Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Can

Brief 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)

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Number of Patients Who Develop Significant Drug-related Adverse Events. [ Time Frame: 90 Days ]

Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.


Original Primary Outcome: Evaluate the safety of standard (50mg) versus a higher dose(150mg) of MK0991 in patients treated for invasive candidiasis, by the proportion of patients who develop significant drug related adverse events.

Current Secondary Outcome: Number of Patients With a Favorable Overall Response. [ Time Frame: 90 Days ]

Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy.


Original Secondary Outcome: Comparison of the proportion of patients with a favorable clinical and microbiological response at the end of treatment with either standard dosing (50mg) or higher doses (150mg) if Caspofungin

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: November 4, 2005
Date Started: January 2006
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017