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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: Completed Phase 1 study of Candidemia and Invasive Candidiasis, sponsored by Astellas Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00608335 record still lists
NCT00608335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 404-participant average among 8 other Candidemia trials with a reported enrollment target (79% lower).
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 lists 13 locations in 6 states (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
Similar trials for Candidemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00608335's enrollment target sits among peer trials
84 8th of 8 higher than 1 of 8 other Candidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Candidemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
COMPLETED · Phase 1
-
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
RECRUITING · Phase 3
-
Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia
RECRUITING · Phase 2
-
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
ACTIVE NOT RECRUITING · Phase 3
-
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
COMPLETED · Phase 3
-
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
COMPLETED
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