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)

Merck Sharp & Dohme LLC204 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

204

Conditions

Invasive Candidiasis

Interventions

caspofungin acetateDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Patients Who Develop Significant Drug-related Adverse Events.

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.

Time frame: 90 Days

Secondary Outcomes

Number of Patients With a Favorable Overall Response.

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.

Time frame: 90 Days

Data from ClinicalTrials.gov

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