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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • California
      • Orange, California, United States, 92868
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Missouri
      • Kansas City, Missouri, United States, 64108
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Texas
      • Dallas, Texas, United States, 75390
    • Virginia
      • Charlottesville, Virginia, United States, 22908

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of micafungin plasma pharmacokinetic parameters
Time Frame: Day 4
Day 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Monitor adverse events
Time Frame: 11 or 12 Days
11 or 12 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

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.

General Publications

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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