- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00672841
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
January 20, 2015 updated by: Duke University
Randomized Comparison of β-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive Care Unit 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 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years
- Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
- IV access for administration of study drug
- Subject (or subject's legal representative) able to give written informed consent
Exclusion Criteria:
- History of hypersensitivity or intolerance to echinocandin antifungals
- Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
- Pregnant or lactating women
- Treatment with systemic antifungal therapy within the preceding 7 days
- Documented invasive fungal infection at baseline/screening
- Life expectancy less than 2 days or moribund
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Standard care/empiric therapy group
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Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.
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Experimental: 1
Active surveillance/ preemptive therapy group
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Subjects in the active surveillance arm who develop a single positive β-D-glucan test will receive preemptive anidulafungin intravenously.
Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day.
The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia.
Preemptive therapy will continue for 14 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.
Time Frame: Participants were followed until ICU discharge, an average of 17 days
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Clinical utility was defined as β-D-glucan test performance.
Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis.
True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology.
Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.
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Participants were followed until ICU discharge, an average of 17 days
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Safety and Tolerability of Preemptive Anidulafungin
Time Frame: weekly until ICU discharge
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reported as the Number of Adverse Events Possibly Related to Study Drug
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weekly until ICU discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validate Gene Expression Signatures Predictive of IC
Time Frame: Study Completion, an average of 17 days
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Study Completion, an average of 17 days
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Incidence of Proven or Probable Invasive Fungal Infection (IFI)
Time Frame: Participants were followed until ICU discharge, an average of 17 days
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Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis.
Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria.
However, BDG results were not factored into the EORTC/MSG criteria.
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Participants were followed until ICU discharge, an average of 17 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kimberly E Hanson, MD, UTAH
- Principal Investigator: Barbara D Alexander, MD, Duke
- Principal Investigator: John Perfect, MD, Duke
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
May 4, 2008
First Submitted That Met QC Criteria
May 5, 2008
First Posted (Estimate)
May 6, 2008
Study Record Updates
Last Update Posted (Estimate)
February 6, 2015
Last Update Submitted That Met QC Criteria
January 20, 2015
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Invasive Fungal Infections
- Candidiasis
- Candidiasis, Invasive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Antifungal Agents
- Clotrimazole
- Miconazole
- Anidulafungin
Other Study ID Numbers
- Pro00003161
- GA88517X
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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