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)

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)

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Infections Invasive Fungal Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical and Laboratory evidence of blood stream &/or systemic candida infections

Exclusion criteria

Possible candida contamination
Candida colonization (non invasive infection), urine, cardiac, bone or brain and prosthetic device infections
Acute or moderately severe liver disease
Abnormal liver function tests
Abnormal blood clotting for patients on blood thinners

Treatment and study plan

caspofungin acetate

Drug

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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 Candidiasis in Adults

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Nov 8, 2005
Registry last updated: Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed