Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants

Condition(s) targeted: Candidiasis

Intervention: caspofungin acetate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

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).

Official title: 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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: Pharmacokinetic parameters of drug exposure

Secondary outcome: Safety and tolerability

Minimum age: N/A. Maximum age: 3 Months. Gender(s): Both.

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

Starting date: May 2006
Ending date: December 2006
Last updated: May 15, 2008