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)
- Registration Number
- NCT00250432
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 caspofungin acetate 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. 1 caspofungin acetate 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.
- Primary Outcome Measures
Name Time Method Number of Patients Who Develop Significant Drug-related Adverse Events. 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 Outcome Measures
Name Time Method Number of Patients With a Favorable Overall Response. 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.