NCT00607763

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

A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 4 Months – 23 Months
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.

Conditions

• Invasive Candidiasis
• Esophageal Candidiasis
• Oropharyngeal Candidiasis
• Candidemia

Interventions

Type	Name	Description
DRUG	Micafungin (Mycamine)	IV

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-02-06
• Last updated: 2014-08-20

Locations

6 sites across 1 country: United States