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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608335
• Other study ID #: 9463-CL-2101
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2007
• Est. completion date: September 8, 2011

Study information

• Verified date: July 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 8, 2011
• Est. primary completion date: September 8, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Micafungin
IV

Locations

Country	Name	City	State
South Africa	Benmed Park Clinic	Benoni
South Africa	Grootte Schuur Hospital	Cape Town
South Africa	GCT -Sunnyside Medi-clinic	Lynn East
South Africa	St. Mary's Hospital	Mariannhill
South Africa	Jubilee Hospital	Temba
South Africa	2 Military Hospital	Wynberg
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	Children's Hospital of Orange County	Orange	California
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters (AUCtau, Tmax, and Cmax)		10 - 14 Days
Secondary	Adverse events		Day 1 to End of Study
Secondary	Vital signs		Day 1 to End of Study
Secondary	Hematology and chemistry laboratory tests		Day 1 to End of Study
Secondary	12-lead ECGs and Physical examination		Day 1 to End of Study

External Links

•   Link to results on the Astellas Clinical Study Results website