Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungal Infection
Intervention: caspofungin acetate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.
Secondary outcome: Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
Eligibility
Minimum age: 3 Months.
Maximum age: 24 Months.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: February 2006
Ending date: February 2007
Last updated: December 23, 2007
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