NCT00608335

Study of Mycamine® in Children 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 Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study. At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.

Conditions

• Oropharyngeal Candidiasis
• Candidemia
• Invasive Candidiasis
• Esophageal Candidiasis

Interventions

Type	Name	Description
DRUG	Micafungin	IV

Timeline

• Start date: 2007-10-14
• Primary completion: 2011-09-08
• Completion: 2011-09-08
• First posted: 2008-02-06
• Last updated: 2024-11-18

Locations

13 sites across 2 countries: United States, South Africa