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NCT00672841 · ClinicalTrials.gov registry record · NA
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT00672841 is a NA study that has completed, run by Duke University. The registered enrollment target is 64 participants.
The verdict
NCT00672841, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
Interventions
- DRUG Preemptive Therapy with Anidulafungin
- DRUG Empiric antifungal therapy based on physician discretion.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00672841
The ClinicalTrials.gov registry entry for NCT00672841 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Preemptive Therapy with Anidulafungin is the first listed.
NCT00672841 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00672841 about?
NCT00672841 is a clinical study titled "β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients". This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and ran...
What is the current status of trial NCT00672841?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2008-06. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00672841?
The interventions under investigation include: Preemptive Therapy with Anidulafungin (DRUG), Empiric antifungal therapy based on physician discretion. (DRUG).
Who is sponsoring clinical trial NCT00672841?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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