NCT00250432

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)

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 Candidiasis in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Invasive Candidiasis

Interventions

Type	Name	Description
DRUG	caspofungin acetate	Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of \~2 hrs. Duration of Treatment - 14-90 days.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-01-01
• Completion: 2008-03-01
• First posted: 2005-11-08
• Last updated: 2017-03-24
• Results posted: 2009-03-24