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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00607763
First received: January 23, 2008
Last updated: August 19, 2014
Last verified: August 2014
  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 (Mycamine)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


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 ]

Enrollment: 9
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Micafungin Drug: Micafungin (Mycamine)
IV
Other Name: FK463

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607763

Locations
United States, California
Los Angeles, California, United States, 90095
Orange, California, United States, 92868
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Missouri
Kansas City, Missouri, United States, 64108
United States, Texas
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00607763     History of Changes
Other Study ID Numbers: 9463-CL-2102
Study First Received: January 23, 2008
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Antifungal
Echinocandin
Candidiasis
Micafungin

Additional relevant MeSH terms:
Candidemia
Candidiasis
Candidiasis, Invasive
Fungemia
Infection
Inflammation
Mycoses
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Micafungin
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014