Clinical Trial: A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in Intensive Care Unit (ICU) Patients

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional



Official Title: Pilot Study of Biomarkers in Invasive Candidiasis in Intensive Care Unit (ICU) Patients

Brief Summary:

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:

  1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
  2. To evaluate the kinetics of positive biomarkers after initiation of antifungal therapy in patients with candidemia;
  3. 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.