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Completed

NCT Number: NCT00818584

An 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

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Key information

Conditions

Candida Torulopsis

Age range

48 hour–120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Birmingham, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micafungin

Drug

IV Administration

Other names: Mycamine, FK463

Primary outcomes

  1. Assessment of micafungin plasma pharmacokinetic parameters

    Time frame: Day 4

Secondary outcomes

  1. Monitor adverse events

    Time frame: 11 or 12 Days

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 7, 2009
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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