Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)

A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.

The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).

Inclusion Criteria:

• Neonates and infants <3 months of age
• Patient has a body weight greater than or equal to 500 grams
• Patient has documented or highly suspected Candida infection

Exclusion Criteria:

• Patient is greater than 3 months of age
• Patient has a body weight of less than 500 grams
• Patient does not meet certain laboratory testing criteria
• Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
• Patient has documented HIV infection of any stage
• Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class