Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
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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).
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.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
up to 3 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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