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. - MK-0991 High Dose Study
Phase 1
- Conditions
- Candidiasis (invasive)MedDRA version: 8.0 Level: LLT Classification code 10007152
- Registration Number
- EUCTR2005-004504-36-BE
- Lead Sponsor
- Merck Sharp & Dohme BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Clinical and microbiological (culture-proven) evidence of blood stream &/or systemic Candida infections
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) Possible Candida contamination
2) Candida colonization ( non invasive infection), or Candida involvement of urine, heart valve, ,bone, cerebral spinal fluid, or
prosthetic devices.
3) Acute or moderately severe liver disease
4) Abnormal liver function tests
5) Abnormal blood clotting for patients on blood thinners
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method