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

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.
 
ClinicalTrials.gov Identifier: NCT00818584
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE January 6, 2009
First Posted Date  ICMJE January 7, 2009
Last Update Posted Date March 6, 2013
Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
Assessment of micafungin plasma pharmacokinetic parameters [ Time Frame: Day 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00818584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
Monitor adverse events [ Time Frame: 11 or 12 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Official Title  ICMJE A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Brief Summary This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Detailed Description Subjects will be stratified by weight to receive one of two doses of study drug
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Candida
Intervention  ICMJE Drug: Micafungin
IV Administration
Other Names:
  • Mycamine
  • FK463
Study Arms  ICMJE
  • Experimental: 1. micafungin lower dose
    Intervention: Drug: Micafungin
  • Experimental: 2. micafungin higher dose
    Intervention: Drug: Micafungin
Publications * Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sánchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2009)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 120 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818584
Other Study ID Numbers  ICMJE 9463-CL-2104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Use Central Contact Astellas Pharma US, Inc.
PRS Account Astellas Pharma Inc
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP