NCT01045798

Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)

MSG-04 (Also Known as Merck Caspofungin Protocol 067): A Pilot, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Caspofungin Empirical Therapy for Invasive Candidiasis in High-Risk Patients in the Critical Care Setting

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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%).

Conditions

• Invasive Candidiasis

Interventions

Type	Name	Description
DRUG	Caspofungin acetate	70 mg of caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
DRUG	Placebo	Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-01-11
• Last updated: 2017-03-24
• Results posted: 2013-05-10