A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in Intensive Care Unit (ICU) Patients
|ClinicalTrials.gov Identifier: NCT01734525|
Recruitment Status : Unknown
Verified November 2012 by Marcio Nucci, Federal University of Rio de Janeiro.
Recruitment status was: Recruiting
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
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. Likewise, analyzing the kinetics of these biomarkers in patients with candidemia/invasive candidiasis would help to define their usefulness in monitoring treatment.
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 evaluate the kinetics of positive biomarkers after initiation of antifungal therapy in patients with 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, unexplanied 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. Blood will oe collected for determination of 1,3 beta-D-glucan on days 7, 10, 14, 17, 21, 24 and 28.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Biomarkers in Invasive Candidiasis in Intensive Care Unit (ICU) Patients|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||September 2013|
Experimental: One arm
Patients at risk will receive therapy with anidulafungin
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
- Exploratory analysis of the kinetics of 1,3 beta-D-glucan in hig-risk patients [ Time Frame: 30 days ]The main interst is to evaluate the kinetics of 1,3 beta-D-glucan in hig-risk patients receiving anidulafungin.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734525
|Federal University of Rio de Janeiro||Recruiting|
|Rio de Janeiro, RJ, Brazil, 21941913|
|Contact: Marcio Nucci, MD 5521-25622463 email@example.com|
|Sub-Investigator: Simone A Nouer, MD|
|Study Chair:||Marcio Nucci, MD||Universidade Federal do Rio de Janeiro|