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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Fungal Infection

Treatments

Drug: caspofungin acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00292071

MK0991-042

0991-042

2005_099

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

3 to 24 months old

Volunteers

No Healthy Volunteers

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.