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COMPLETED Phase 1

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

NCT00608335 · View on ClinicalTrials.gov ↗

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

51 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00608335 reports 13 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00608335?

The interventions under investigation include: Micafungin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00608335?

This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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