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

Phase 2

Completed

• Conditions: Candidiasis

• Registration Number: NCT00330395
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-26
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of drug exposure

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability