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An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00818584
First received: January 6, 2009
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection


Condition Intervention Phase
Candida
 Drug: Micafungin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of micafungin plasma pharmacokinetic parameters [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitor adverse events [ Time Frame: 11 or 12 Days ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: August 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. micafungin lower dose Drug: Micafungin
IV Administration
Other Names:
  • Mycamine
  • FK463
Experimental: 2. micafungin higher dose Drug: Micafungin
IV Administration
Other Names:
  • Mycamine
  • FK463

Detailed Description:

Subjects will be stratified by weight to receive one of two doses of study drug

  Eligibility

Ages Eligible for Study:   up to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
  • Infant has sufficient venous access to permit study drug dosing
  • Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry

Exclusion Criteria:

  • Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
  • Infant has received an echinocandin within one month prior to study entry
  • Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
  • Infant has a life expectancy of less than 96 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818584

Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
Orange, California, United States, 92868
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Missouri
Kansas City, Missouri, United States, 64108
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Texas
Dallas, Texas, United States, 75390
United States, Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Link to results on JAPIC  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00818584     History of Changes
Obsolete Identifiers: NCT00906230
Other Study ID Numbers: 9463-CL-2104
Study First Received: January 6, 2009
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Micafungin
Candida
Neonates
Mycamine
FK463

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

ClinicalTrials.gov processed this record on May 19, 2013