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Completed

NCT Number: NCT00607763

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

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

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Esophageal Candidiasis Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Oropharyngeal Candidiasis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

4 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is ≥4 months to < 24 months
  • Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
  • Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion criteria

  • 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)
  • Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
  • Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
  • Subject has received treatment with an echinocandin within one week prior to first dosing
  • Subject status is unstable and subject is unlikely to complete all study required procedures

Treatment and study plan

micafungin (Mycamine)

Drug

IV

Other names: FK463

Primary outcomes

  1. Evaluation of Micafungin pharmacokinetics

    Time frame: 10 - 14 Days

Secondary outcomes

  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

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 (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2008
Registry last updated
Aug 20, 2014

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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