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

NCT00608335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-11-18

No results posted yet for this study

Summary

Children with fungal infections will be divided into two groups by weight. Children weighing \< 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing \> 25 kg.

Conditions

  • Oropharyngeal Candidiasis
  • Candidemia
  • Invasive Candidiasis
  • Esophageal Candidiasis

Interventions

DRUG

Micafungin

IV

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-14
Primary Completion
2011-09-08
Completion
2011-09-08

Countries

  • United States
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608335 on ClinicalTrials.gov