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)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Candidiasis
Intervention: caspofungin acetate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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)
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Patients Who Develop Significant Drug-related Adverse Events.
Secondary outcome: Number of Patients With a Favorable Overall Response.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Related publications: Betts RF, Nucci M, Talwar D, Gareca M, Queiroz-Telles F, Bedimo RJ, Herbrecht R, Ruiz-Palacios G, Young JA, Baddley JW, Strohmaier KM, Tucker KA, Taylor AF, Kartsonis NA; Caspofungin High-Dose Study Group. A Multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 Jun 15;48(12):1676-84. doi: 10.1086/598933.
Starting date: January 2006
Last updated: October 31, 2014
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