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NCT00005912 · ClinicalTrials.gov registry record · Phase 1
Voriconazole to Prevent Systemic Fungal Infections in Children
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00005912: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00005912 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005912, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will examine how children's bodies metabolize and eliminate the anti-fungal drug voriconazole. The results will yield information needed to make recommendations for safe and effective dosing of the drug in children. Children with reduced immune function-such as those receiving drugs for cancer treatment-are at high risk for serious fungal infections. Children between 2 and 12 years old who need treatment to prevent fungal infections may be eligible for this study. Candidates will be screened with a physical examination, eye examination, and blood and urine tests. Children in the study will be hospitalized for 21 days. They will receive voriconazole twice a day (every 12 hours) for 8 days, infused through a vein over a period of 1 to 2 hours. The dose will be determined based on the individual child's weight. Blood samples will be collected at various intervals before and after the infusions on days 1, 2, 4 and 8 to determine the amount of drug in the blood. On day 8, the child will have another physical and eye examination, as well as additional blood and urine tests. If additional treatment is required, voriconazole may be continued for up to day 21. (Children who require the drug for more than 21 days may receive it under another research protocol.) On the last day of treatment, the child will have another physical examination, and blood and urine tests. These procedures will be repeated again at 30 to 35 days following the last dose of drug. A small sample of blood will also be analyzed for genetic information related to the rate of metabolism of voriconazole-that is, how fast or slow it is cleared (eliminated) by the liver. Voriconazole is effective against several different fungi. It may protect children against serious fungal infections with fewer side effects than standard available therapy.
Interventions
- DRUG Voriconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2000-06 |
| Est. Completion | 2001-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005912
The ClinicalTrials.gov registry entry for NCT00005912 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Voriconazole is the first listed.
NCT00005912 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005912 about?
NCT00005912 is a clinical study titled "Voriconazole to Prevent Systemic Fungal Infections in Children". This study will examine how children's bodies metabolize and eliminate the anti-fungal drug voriconazole. The results will yield information needed to make recommendations for safe and effective dosing of the drug in children. Children with reduced immune function-such as those receiving drugs for c...
What is the current status of trial NCT00005912?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2000-06. Estimated completion is 2001-01.
What interventions are being tested in trial NCT00005912?
The interventions under investigation include: Voriconazole (DRUG).
Who is sponsoring clinical trial NCT00005912?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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