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

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: NCT00607763
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Invasive Candidiasis Esophageal Candidiasis Oropharyngeal Candidiasis Candidemia Drug: Micafungin (Mycamine) Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1. Micafungin Drug: Micafungin (Mycamine)
IV
Other Name: FK463


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Micafungin pharmacokinetics [ Time Frame: 10 - 14 Days ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   4 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607763


Locations
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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
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Study Director: Central Contact Astellas Pharma Global Development
More Information
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Additional Information:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00607763    
Other Study ID Numbers: 9463-CL-2102
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
Antifungal
Echinocandin
Candidiasis
Micafungin
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
 Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Micafungin
Antifungal Agents
Anti-Infective Agents