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)

Study Overview
=================
Brief 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)

Official 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

Conditions
-----------------
Invasive Candidiasis

Intervention / Treatment
-----------------
* Drug: caspofungin acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>50 mg intravenous (IV) infusion (diluted with 9% saline) administered daily (following a 70-mg IV loading dose on Day 1), over the course of  2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection. | Drug: caspofungin acetate<br>* 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.<br>|
| Experimental: 2<br>150 mg intravenous (IV) infusion (diluted with 9% saline) administered daily, over the course of  2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection. | Drug: caspofungin acetate<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 Days |