Clinical Trial: Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: MSG-04 (Also Known as Merck Caspofungin Protocol 067): A Pilot, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Caspofungin Empirical Therapy for Invasive Cand
Brief Summary: This is a pilot feasibility study that investigates antifungal therapy with caspofungin in patients at high-risk for developing invasive candidiasis in a critical care setting.
Detailed Summary: Hypothesis: In high-risk non-neutropenic participants in the ICU, the proportion of participants discontinued from study therapy in order to be empirically treated with antifungal therapy for suspected candidiasis outside of the context of this protocol is less than 20% (i.e., the upper bound of the 95% confidence interval for the observed proportion is less than 20%).
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study. [ Time Frame: 1 to 14 days ]
The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol.
Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug.
Original Primary Outcome: The proportion of patients discontinued from study therapy to be treated with empirical antifungal therapy outside of the context of the study [ Time Frame: 1 to 14 days ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: January 7, 2010
Date Started: December 2010
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017
