Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Caspofungin; Echinocandins

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.