Clinical trial NCT00608335: Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oropharyngeal Candidiasis
Candidemia
Invasive Candidiasis
Esophageal Candidiasis
Keywords: Antifungal
Micafungin
Echinocandin
Candidiasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: PK parameters (AUCtau, Tmax, and Cmax)
timeFrame: 10 - 14 Days
Secondary outcomes:
measure: Adverse events
timeFrame: Day 1 to End of Study
measure: Vital signs
timeFrame: Day 1 to End of Study
measure: Hematology and chemistry laboratory tests
timeFrame: Day 1 to End of Study
measure: 12-lead ECGs and Physical examination
timeFrame: Day 1 to End of Study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Benoni
country: South Africa
facility: Benmed Park Clinic
city: Cape Town
country: South Africa
facility: Grootte Schuur Hospital
city: Lynn East
country: South Africa
facility: GCT -Sunnyside Medi-clinic
city: Mariannhill
country: South Africa
facility: St. Mary's Hospital
city: Temba
country: South Africa
facility: Jubilee Hospital
city: Wynberg
country: South Africa
facility: 2 Military Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References: