| May 20, 2004 |
| February 14, 2008 |
| August 2004 |
| February 2006 (final data collection date for primary outcome measure) |
| Favorable overall response rate |
| Same as current |
| Complete list of historical versions of study NCT00083343 on ClinicalTrials.gov Archive Site |
- Favorable overall response rate on Day 10 of caspofungin therapy
- Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy
|
- 1)Favorable overall response rate on Day 10 of caspofungin therapy
- 2)Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy
|
| |
| Caspofungin for the Treatment of Non-Blood Candida Infections |
| A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults With Invasive Candida Infections (Excluding Patients With Candidemia as the Sole Site of Infection) |
Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection. |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Candidiasis |
| Drug: MK0991, caspofungin acetate/Duration of Treatment: variable |
| |
| Petrovic J, Ngai A, Bradshaw S, Williams-Diaz A, Taylor A, Sable C, Vuocolo S, Kartsonis N. Efficacy and safety of caspofungin in solid organ transplant recipients. Transplant Proc. 2007 Dec;39(10):3117-20. |
| |
| Completed |
| 50 |
|
| February 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- All patients must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry.
- The patient must also have clinical evidence of Candida infection (e.g., oral temperature >100 degrees Fahrenheit, signs of inflammation from infected site, systolic blood pressure <90) within 96 hours of study entry.
- The patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment.
Exclusion Criteria:
- Patients whose only site of Candida infection was the bloodstream.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00083343 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2004_102, Formerly-0404NBCI, MK0991-045 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| February 2008 |