Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
Fungal Infection
About this trial
This is an interventional treatment trial for Fungal Infection
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
Other
1
2
IV caspofungin acetate (50 mg/m²/day)
IV caspofungin acetate (70 mg/m²/day)