Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Echinocandins; Micafungin

Criteria

Inclusion Criteria:

1. Subject is ≥4 months to < 24 months

2. Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis

3. Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria:

1. Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)

2. Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study

3. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals

4. Subject has received treatment with an echinocandin within one week prior to first dosing

5. Subject status is unstable and subject is unlikely to complete all study required procedures