Negative Beta Glucan in ICU Patients
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|ClinicalTrials.gov Identifier: NCT01734525|
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : July 8, 2019
Last Update Posted : July 8, 2019
This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.
Therefore, the objectives of this study are:
- To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
- To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.
|Condition or disease||Intervention/treatment||Phase|
|Candidemia||Drug: Anidulafungin||Phase 4|
Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.
Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.
If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Patients at risk will receive therapy with anidulafungin
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
- Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin [ Time Frame: 30 days ]The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
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): NCT01734525
|Federal University of Rio de Janeiro|
|Rio de Janeiro, RJ, Brazil, 21941913|
|Study Chair:||Marcio Nucci, MD||Universidade Federal do Rio de Janeiro|