Status:
COMPLETED
Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Fungal Infection
Eligibility:
All Genders
3-24 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00292071
Start Date
May 1 2004
End Date
July 1 2006
Last Update
February 23 2017
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