| February 14, 2006 |
| October 26, 2009 |
| May 2004 |
| August 2007 (final data collection date for primary outcome measure) |
| Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. [ Time Frame: 28 Days ] [ Designated as safety issue: No ] |
| Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. |
| Complete list of historical versions of study NCT00292071 on ClinicalTrials.gov Archive Site |
| Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ] |
| Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. |
| |
| Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia |
| A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Fungal Infection |
| Drug: caspofungin acetate |
- Other: IV caspofungin acetate (50 mg/m²/day)
- Other: IV caspofungin acetate (70 mg/m²/day)
|
| 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. Epub 2008 Dec 29. |
| |
| Completed |
| 16 |
| August 2007 |
| August 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient is 3 to 24 months of age with one or more of the following conditions:
- Leukemia, lymphoma, or other cancers
- Bone marrow or peripheral stem transplantation
- High dose chemotherapy leading to a decrease in white blood cells
- Aplastic anemia
- Patient has an absolute neutrophil count <500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever > 38 degreesC (oral or oral equivalent) within 72 hours of screening.
Exclusion Criteria:
- Patient is <3 months or >24 months of age at the time of study drug administration
- Patient has proven or probable invasive fungal infection at the time of enrollment
- Patient has certain blood clotting or liver function abnormalities
- Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
- Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.
|
| Both |
| 3 Months to 24 Months |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00292071 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2005_099, MK0991-042 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| October 2009 |
