(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis — CandiSep  

Septic Shock Clinical Trial

Official title: (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection Versus Culture Based Diagnosis in Patients With Severe Sepsis or Septic Shock

Status Completed

Clinical Trial Summary

This prospective randomized multicenter study evaluates whether the decision to prescribe antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and a high risk of invasive candida infection.

Clinical Trial Description

(1,3)-β-D-glucan is a component of the cell wall of many fungi including candida spp. and is present in the blood of patients with invasive candida infection (ICI). Several studies showed a good diagnostic accuracy (1,3)-β-D-glucan in predicting ICI. However, others have challenged (1,3)-β-D-glucan as a diagnostic tool in critically ill patients as many substances used in the intensive care unit might affect the results of the assay. The goal of this study is to investigate whether (1,3)-β-D-glucan can early identify sepsis patients in need of antifungal therapy. Patients randomized to the standard of care group receive antifungals depending on microbiological results according to current guidelines. Patients randomized to the BDG group receive antifungals depending on the (1,3)-β-D-glucan plasma concentration on day 1 and day after diagnosing sepsis. Therapy may be modified according to microbiological results. ;

Related Conditions & MeSH terms

• Candidiasis
• Infections
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

• NCT number: NCT02734550
• Study type: Interventional
• Source: Center for Sepsis Control and Care, Germany
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Completion date: September 17, 2019