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

• Status: Completed
• Trial end date: 2011-09-08
• Target enrollment: 0
• Participant gender: All

Summary

Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.

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

Details

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

Criteria

Inclusion Criteria:

1. Subject is 2 to 16 years inclusive

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