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 (MSD)

Status and phase: Completed; Phase 3

Conditions: Invasive Candidiasis

Treatments: Drug: caspofungin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00250432

2005_085

0991-801

Details and patient eligibility

About

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)

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Drug: caspofungin acetate

2

Experimental group

Description:

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.

Treatment:

Drug: caspofungin acetate