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NCT00001810 · ClinicalTrials.gov registry record · Phase 3
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
A Phase 3 study of Mycoses and Candidiasis, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT00001810: Completed Phase 3 study of Mycoses and Candidiasis, sponsored by National Cancer Institute (NCI).
NCT00001810 is a Phase 3 study of Mycoses and Candidiasis that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 300 participants, roughly in line with the 304-participant average among 7 other Mycoses trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001810, a Phase 3 study of Mycoses and Candidiasis, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase II multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.
Conditions Studied
Interventions
- DRUG Voriconazole
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 1999-04 |
| Est. Completion | 2000-10 |
| Phase | Phase 3 |
What the finished NCT00001810 record still lists
NCT00001810 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 304-participant average among 7 other Mycoses trials with a reported enrollment target.
The record links to 4 conditions, with Mycoses appearing as the primary indexed condition, and to 1 intervention - of which Voriconazole is the first listed.
NCT00001810 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001810 about?
NCT00001810 is a clinical study titled "An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections". The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections i...
What is the current status of trial NCT00001810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 1999-04. Estimated completion is 2000-10.
What conditions does trial NCT00001810 study?
This clinical trial studies the following conditions: Mycoses, Candidiasis, Fungemia, Aspergillosis.
What interventions are being tested in trial NCT00001810?
The interventions under investigation include: Voriconazole (DRUG).
Who is sponsoring clinical trial NCT00001810?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001810 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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