Dataset Information

(1,3)-?-D-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial.

ABSTRACT:

Background

(1,3)-?-D-Glucan has been widely used in clinical practice for the diagnosis of invasive Candida infections. However, such serum biomarker showed potential to guide antimicrobial therapy in order to reduce the duration of empirical antifungal treatment in critically ill septic patients with suspected invasive candidiasis.

Methods

This was a single-centre, randomized, open-label clinical trial in which critically ill patients were enrolled during the admission to the intensive care unit (ICU). All septic patients who presented invasive Candida infection risk factors and for whom an empirical antifungal therapy was commenced were randomly assigned (1:1) in those stopping antifungal therapy if (1,3)-?-D-glucan was negative ((1,3)-?-D-glucan group) or those continuing the antifungal therapy based on clinical rules (control group). Serum 1,3-?-D-glucan was measured at the enrolment and every 48/72?h over 14?days afterwards. The primary endpoint was the duration of antifungal treatment in the first 30?days after enrolment.

Results

We randomized 108 patients into the (1,3)-?-D-glucan (n?=?53) and control (n?=?55) groups. Median [IQR] duration of antifungal treatment was 2?days [1-3] in the (1,3)-?-D-glucan group vs. 10?days [6-13] in the control group (between-group absolute difference in means, 6.29?days [95% CI 3.94-8.65], p?ConclusionsIn critically ill septic patients admitted to the ICU at risk of invasive candidiasis, a (1,3)-?-D-glucan-guided strategy could reduce the duration of empirical antifungal therapy. However, the safety of this algorithm needs to be confirmed in future, multicentre clinical trial with a larger population.

Trial registration

ClinicalTrials.gov, NCT03117439 , retrospectively registered on 18 April 2017.

SUBMITTER: De Pascale G

PROVIDER: S-EPMC7487510 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

(1,3)-β-D-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial.

De Pascale Gennaro G Posteraro Brunella B D'Arrigo Sonia S Spinazzola Giorgia G Gaspari Rita R Bello Giuseppe G Montini Luca Maria LM Cutuli Salvatore Lucio SL Grieco Domenico Luca DL Di Gravio Valentina V De Angelis Giulia G Torelli Riccardo R De Carolis Elena E Tumbarello Mario M Sanguinetti Maurizio M Antonelli Massimo M

Critical care (London, England) 20200905 1

<h4>Background</h4>(1,3)-β-D-Glucan has been widely used in clinical practice for the diagnosis of invasive Candida infections. However, such serum biomarker showed potential to guide antimicrobial therapy in order to reduce the duration of empirical antifungal treatment in critically ill septic patients with suspected invasive candidiasis.<h4>Methods</h4>This was a single-centre, randomized, open-label clinical trial in which critically ill patients were enrolled during the admission to the int ...[more]

PMID: 32891170

Similar Datasets

Project description:BACKGROUND:The time to diagnosis of invasive Candida infection (ICI) is often too long to initiate timely antifungal therapy in patients with sepsis. Elevated serum (1,3)-?-D-glucan (BDG) concentrations have a high diagnostic sensitivity for detecting ICI. However, the clinical significance of elevated BDG concentrations is unclear in critically ill patients. The goal of this study is to investigate whether measurement of BDG in patients with sepsis and a high risk for ICI can be used to decrease the time to empiric antifungal therapy and thus, increase survival. METHODS/DESIGN:This prospective multicenter open randomized controlled trial is being conducted in 19 German intensive care units. All adult patients with severe sepsis or septic shock and an increased risk for ICI are eligible for enrolment. Risk factors are total parenteral nutrition, previous abdominal surgery, previous antimicrobial therapy, and renal replacement therapy. Patients with proven ICI or those already treated with systemic antifungal substances are excluded. Patients are allocated to a BDG or standard care group. The standard care group receives targeted antifungal therapy as necessary. In the BDG group, BDG serum samples are taken after randomization and 24 h later. Antifungal therapy is initiated if BDG is ?80 pg/ml in at least one sample. We plan to enroll 312 patients. The primary outcome is 28-day mortality. Other outcomes include antifungal-free survival within 28 days after enrolment, time to antifungal therapy, and the diagnostic performance of BDG compared to other laboratory tests for early ICI diagnosis. The statistical analysis will be performed according to the intent-to-treat principle. DISCUSSION:Because of the high risk of death, American guidelines recommend empiric antifungal therapy in sepsis patients with a high risk of ICI despite the limited evidence for such a recommendation. In contrast, empiric antifungal therapy is not recommended by European guidelines. BDG may offer a way out of this dilemma since BDG potentially identifies patients in need of early antifungals. However, the evidence for such an approach is inconclusive. This clinical study will generate solid evidence for health-care providers and authors of guidelines for the use of BDG in critically ill patients. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02734550 . Registered 12 April 2016.