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

Astellas

Status and phase: Completed; Phase 1

Conditions: Oropharyngeal Candidiasis; Candidemia; Invasive Candidiasis; Esophageal Candidiasis

Treatments: Drug: Micafungin (Mycamine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00607763

9463-CL-2102

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 4 to 23 months old

Volunteers: No Healthy Volunteers

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

Trial design

9 participants in 1 patient group

1. Micafungin

Experimental group

Treatment:

Drug: Micafungin (Mycamine)