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

This study is currently recruiting participants.
Verified by Astellas Pharma Inc, September 2008

Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00608335
  Purpose

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 Intervention Phase
Invasive Candidiasis
Esophageal Candidiasis
Oropharyngeal Candidiasis
Candidemia
Drug: Micafungin
Phase I

MedlinePlus related topics:   Esophagus Disorders    Fungal Infections    Molds    Yeast Infections   

ChemIDplus related topics:   Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole    Micafungin    FK 463   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • PK parameters (AUCtau, Tmax, and Cmax) [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
  • Hematology and chemistry laboratory tests [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
  • 12-lead ECGs and Physical examination [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   October 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
3.0mg
Drug: Micafungin
IV
2: Experimental
4.5mg
Drug: Micafungin
IV

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.

A total of 24 subjects, 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). Enrollment in an individual age cohort in Group 1 will complete before enrollment in the same age cohort in Group 2 can begin. A total of 36 subjects, 12 in each of three age ranges, will be enrolled in Group 2 (safety).

  Eligibility
Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Subject is 2 to 16 years inclusive
  2. Subject has 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608335

Contacts
Contact: Astellas Pharma US Medical Information     800-888-7704 ext 5473     clintrials.info@us.astellas.com    

Locations
United States, California
Recruiting
      Orange, California, United States, 92868
United States, Minnesota
Recruiting
      Minneapolis, Minnesota, United States, 55455
United States, Missouri
Recruiting
      Kansas City, Missouri, United States, 64108
United States, North Carolina
Recruiting
      Durham, North Carolina, United States, 27710
United States, Texas
Recruiting
      Dallas, Texas, United States, 75390
Recruiting
      Houston, Texas, United States, 77030
South Africa
Recruiting
      Lynn East, South Africa, 0039
Recruiting
      Benoni, South Africa, 1500
Terminated
      Mariannhill, South Africa, 3610
Recruiting
      Wynberg, South Africa, 7824
Terminated
      Temba, South Africa, 0400
Recruiting
      Cape Town, South Africa, 7924

Sponsors and Collaborators
Astellas Pharma Inc

Investigators
Study Director:     Central Contact     Astellas Pharma US, Inc.    
  More Information


Responsible Party:   Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registry )
Study ID Numbers:   9463-CL-2101
First Received:   January 23, 2008
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00608335
Health Authority:   United States: Food and Drug Administration;   South Africa: Medicines Control Council

Keywords provided by Astellas Pharma Inc:
Antifungal  
Echinocandin  
Candidiasis  
Micafungin  

Study placed in the following topic categories:
Mycoses
Digestive System Diseases
Esophageal disorder
Candidiasis
Clotrimazole
Gastrointestinal Diseases
Miconazole
Tioconazole
Esophageal Diseases
Micafungin

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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