CandiSep

Prospective randomized study of (1,3)-β-D-glucan guided diagnosis of invasive Candida infection versus culture-based diagnosis in patients with severe sepsis or septic shock and high risk of invasive Candida infections

Dr. Frank Bloos, PhD

Principal Investigator,
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

Not only bacteria, but also infections of blood and abdominal cavity by candida (yeasts) can cause severe sepsis. Due to acquired weakness of the immune system and the necessary use of broad spectrum antibiotics intensive care unit patients are especially susceptible to invasive candida infections. Mortality is high. Detection of candida from blood by classic microbiological testing is only successful in half of all cases and takes several days. But already a delay of one day in the initiation of treatment with activity against candida results in a significantly higher mortality.

Therefore alternative strategies for the detection of candida infections are necessary. (1,3)-b-D-Glucan (BDG) is an important cell wall component of candida, but also of other fungal species. An assay (FungitellÒ) for its detection from blood is available. Available studies show that this test is positive in about 80% of critically ill patients with invasive candida infections, mostly several days before successful microbiological detection. A relatively high rate of false positive results is, however, problematic. Studies addressing the question whether its use in critically ill patients can improve treatment and outcome are lacking.

We want to close this gap in evidence with a multicentric clinical trial. We want to include 368 critically ill patients with new onset severe sepsis and risk factors for invasive candida infections. In addition to microbiological tests BDG will be measured. The result will be reported to the treating clinicians in the intervention group only, where it can result in early initiation of adequate therapy. In the control group the test result will not be available for the planning of therapy. We will evaluate whether the inclusion of BDG measurement can reduce 28-day mortality in risk groups.