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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00608335
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : March 13, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Invasive Candidiasis Esophageal Candidiasis Oropharyngeal Candidiasis Candidemia Drug: Micafungin Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : October 2007
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1. Micafungin 3.0 mg Drug: Micafungin
Other Name: FK463
Experimental: 2. Micafungin 4.5 mg Drug: Micafungin
Other Name: FK463

Primary Outcome Measures :
  1. PK parameters (AUCtau, Tmax, and Cmax) [ Time Frame: 10 - 14 Days ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Day 1 to End of Study ]
  2. Vital signs [ Time Frame: Day 1 to End of Study ]
  3. Hematology and chemistry laboratory tests [ Time Frame: Day 1 to End of Study ]
  4. 12-lead ECGs and Physical examination [ Time Frame: Day 1 to End of Study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00608335

United States, California
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Texas Children's Hospital
Houston, Texas, United States, 77030
South Africa
Benmed Park Clinic
Benoni, South Africa, 1500
Grootte Schuur Hospital
Cape Town, South Africa, 7924
GCT -Sunnyside Medi-clinic
Lynn East, South Africa, 0039
St. Mary's Hospital
Mariannhill, South Africa, 3610
Jubilee Hospital
Temba, South Africa, 0400
2 Military Hospital
Wynberg, South Africa, 7824
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Senior Medical Director Astellas Pharma Global Development

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00608335     History of Changes
Other Study ID Numbers: 9463-CL-2101
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: September 2011

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Antifungal Agents
Anti-Infective Agents