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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

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