β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
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|ClinicalTrials.gov Identifier: NCT00672841|
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : April 22, 2013
Last Update Posted : February 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Invasive Candidiasis||Drug: Preemptive Therapy with Anidulafungin Drug: Empiric antifungal therapy based on physician discretion.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2011|
Active Comparator: 2
Standard care/empiric therapy group
Drug: Empiric antifungal therapy based on physician discretion.
Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.
Active surveillance/ preemptive therapy group
Drug: Preemptive Therapy with Anidulafungin
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 Name: Eraxis
- 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 ]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.
- Safety and Tolerability of Preemptive Anidulafungin [ Time Frame: weekly until ICU discharge ]reported as the Number of Adverse Events Possibly Related to Study Drug
- Validate Gene Expression Signatures Predictive of IC [ Time Frame: Study Completion, an average of 17 days ]
- Incidence of Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: Participants were followed until ICU discharge, an average of 17 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672841
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kimberly E Hanson, MD||Utah|
|Principal Investigator:||Barbara D Alexander, MD||Duke|
|Principal Investigator:||John Perfect, MD||Duke|