Phase 3
N=204
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)
Invasive Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT00250432 ↗Enrolled (actual)
204
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Number of Patients Who Develop Significant Drug-related Adverse Events. — 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- caspofungin acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Develop Significant Drug-related Adverse Events. |
2; 3 | — |
| SECONDARY Number of Patients With a Favorable Overall Response. |
73; 74 | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT00250432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.