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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2007-10-14 |
| Est. Completion | 2011-09-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
Learn More About Clinical Trials
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Related
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