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

Candidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607763
• Other study ID #: 9463-CL-2102
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2008
• Last updated: August 19, 2014
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 23 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Esophageal Candidiasis
• Invasive Candidiasis
• Oropharyngeal Candidiasis

Intervention

Drug:
• Micafungin (Mycamine)
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Micafungin pharmacokinetics		10 - 14 Days	No
Secondary	Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation		Day 1 to End of Study	No

External Links

•   Link to Results on JAPIC - enter 140540 in the JapicCTI-RNo. field