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| ID | Type | Description | Link |
|---|---|---|---|
| Formerly-0404NBCI | |||
| MK0991-045 | |||
| 2004_102 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0991, caspofungin acetate/Duration of Treatment: variable | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable overall response rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18089335 | Background | 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. doi: 10.1016/j.transproceed.2007.10.003. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |