Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
- Registration Number
- NCT00292071
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 caspofungin acetate IV caspofungin acetate (50 mg/m²/day) 2 caspofungin acetate IV caspofungin acetate (70 mg/m²/day)
- Primary Outcome Measures
Name Time Method Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. 28 Days
- Secondary Outcome Measures
Name Time Method Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. 28 Days