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NCT00608335 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Candidemia and Invasive Candidiasis, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
84
Enrollment target
13
Study locations

NCT00608335 is a Phase 1 study of Candidemia and Invasive Candidiasis that has completed, run by Astellas Pharma. The registered enrollment target is 84 participants, below the 404-participant average among 8 other Candidemia trials with a reported enrollment target (79% lower). The trial reports 13 study locations across 6 states.

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The verdict

NCT00608335, a Phase 1 study of Candidemia and Invasive Candidiasis, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
84 participants
Enrollment target
13
Study locations

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.

Interventions

  • DRUG Micafungin

Study Locations (13)

Other

  • Benmed Park Clinic - Benoni
  • Grootte Schuur Hospital - Cape Town
  • GCT -Sunnyside Medi-clinic - Lynn East
  • St. Mary's Hospital - Mariannhill
  • Jubilee Hospital - Themba
  • 2 Military Hospital - Wynberg

California

  • University of California Los Angeles Medical Center - Los Angeles
  • Children's Hospital of Orange County - Orange

Texas

  • University of Texas Southwestern - Dallas
  • Texas Children's Hospital - Houston

Missouri

  • Children's Mercy Hospital - Kansas City

North Carolina

  • Duke University Medical Center - Durham

Oregon

  • Oregon Health and Science University - Portland

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2007-10-14
Est. Completion 2011-09-08
Phase Phase 1

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT00608335

The ClinicalTrials.gov registry entry for NCT00608335 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 404-participant average among 8 other Candidemia trials with a reported enrollment target (79% lower). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Candidemia appearing as the primary indexed condition, and to 1 intervention - of which Micafungin is the first listed.

NCT00608335 reports 13 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Texas.

Frequently Asked Questions

What is clinical trial NCT00608335 about?

NCT00608335 is a clinical study titled "Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug". 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.

What is the current status of trial NCT00608335?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2007-10-14. Estimated completion is 2011-09-08.

What conditions does trial NCT00608335 study?

This clinical trial studies the following conditions: Candidemia, Invasive Candidiasis, Oropharyngeal Candidiasis, Esophageal Candidiasis.

What interventions are being tested in trial NCT00608335?

The interventions under investigation include: Micafungin (DRUG).

Who is sponsoring clinical trial NCT00608335?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00608335 being conducted?

This trial has 13 study locations across California, Missouri, North Carolina, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.