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Published in: Critical Care 1/2020

01-12-2020 | Candidiasis | Research

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

Authors: Gennaro De Pascale, Brunella Posteraro, Sonia D’Arrigo, Giorgia Spinazzola, Rita Gaspari, Giuseppe Bello, Luca Maria Montini, Salvatore Lucio Cutuli, Domenico Luca Grieco, Valentina Di Gravio, Giulia De Angelis, Riccardo Torelli, Elena De Carolis, Mario Tumbarello, Maurizio Sanguinetti, Massimo Antonelli

Published in: Critical Care | Issue 1/2020

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Abstract

Background

(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.

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)-β-d-glucan was negative ((1,3)-β-d-glucan group) or those continuing the antifungal therapy based on clinical rules (control group). Serum 1,3-β-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)-β-d-glucan (n = 53) and control (n = 55) groups. Median [IQR] duration of antifungal treatment was 2 days [1–3] in the (1,3)-β-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 < 0.001). Thirty-day mortality was similar (28.3% [(1,3)-β-d-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-d-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).

Conclusions

In critically ill septic patients admitted to the ICU at risk of invasive candidiasis, a (1,3)-β-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
Appendix
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Metadata
Title
(1,3)-β-d-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial
Authors
Gennaro De Pascale
Brunella Posteraro
Sonia D’Arrigo
Giorgia Spinazzola
Rita Gaspari
Giuseppe Bello
Luca Maria Montini
Salvatore Lucio Cutuli
Domenico Luca Grieco
Valentina Di Gravio
Giulia De Angelis
Riccardo Torelli
Elena De Carolis
Mario Tumbarello
Maurizio Sanguinetti
Massimo Antonelli
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2020
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-020-03265-y

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