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| ID | Type | Description | Link |
|---|---|---|---|
| MK0991-042 | |||
| 2005_099 |
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This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | IV caspofungin acetate (50 mg/m²/day) |
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| 2 | Other | IV caspofungin acetate (70 mg/m²/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin acetate | Drug | (50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. | 28 Days |
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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 |
|---|---|---|---|
| 19114680 | Background | Neely M, Jafri HS, Seibel N, Knapp K, Adamson PC, Bradshaw SK, Strohmaier KM, Sun P, Bi S, Dockendorf MF, Stone JA, Kartsonis NA. Pharmacokinetics and safety of caspofungin in older infants and toddlers. Antimicrob Agents Chemother. 2009 Apr;53(4):1450-6. doi: 10.1128/AAC.01027-08. Epub 2008 Dec 29. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| 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 |