- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818584
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
March 4, 2013 updated by: Astellas Pharma Inc
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Study Overview
Detailed Description
Subjects will be stratified by weight to receive one of two doses of study drug
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
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California
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Orange, California, United States, 92868
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Kentucky
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Louisville, Kentucky, United States, 40202
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Missouri
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Kansas City, Missouri, United States, 64108
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North Carolina
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Durham, North Carolina, United States, 27710
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Texas
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Dallas, Texas, United States, 75390
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Virginia
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Charlottesville, Virginia, United States, 22908
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 days to 3 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1. micafungin lower dose
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IV Administration
Other Names:
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Experimental: 2. micafungin higher dose
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IV Administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Assessment of micafungin plasma pharmacokinetic parameters
Time Frame: Day 4
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Day 4
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Monitor adverse events
Time Frame: 11 or 12 Days
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11 or 12 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
January 6, 2009
First Submitted That Met QC Criteria
January 6, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
March 6, 2013
Last Update Submitted That Met QC Criteria
March 4, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9463-CL-2104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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