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Study of Mycamine® in Infants and Toddlers 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: NCT00607763
  Purpose

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


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, Pharmacokinetics Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Evaluation of Micafungin pharmacokinetics [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:   8
Study Start Date:   October 2007
Estimated Study Completion Date:   September 2008
Estimated Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: Micafungin
IV

Detailed 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.

  Eligibility
Ages Eligible for Study:   4 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Subject is ≥4 months to < 24 months
  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: NCT00607763

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, Kentucky
Recruiting
      Louisville, Kentucky, United States, 40202
United States, Missouri
Recruiting
      Kansas City, Missouri, United States, 64108
United States, Texas
Recruiting
      Dallas, Texas, United States, 75390
Recruiting
      Houston, Texas, United States, 77030

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-2102
First Received:   January 23, 2008
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00607763
Health Authority:   United States: Food and Drug Administration

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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