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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Candidiasis

Treatments: Drug: caspofungin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00330395

2006_025

MK0991-058

0991-058

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)