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

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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

OTHER

Standard of care

Patients are treated according to the ESCMID guidelines. Antifungal therapy is started if fungi are detected in the blood culture or other primary sterile body fluids.

OTHER

(1,3)-β-D-glucan guided therapy

Serum for (1,3)-β-D-glucan measurement is obtained after enrollment and 24 hours later. Antifungal therapy is started if at least one sample is 80 pg/ml or higher. If concomitantly taken microbiological cultures remain negative, antifungal therapy is continued only, if both (1,3)-β-D-glucan were at least 80 pg/ml. Blood cultures or other samples from primary sterile body fluids positive for fungi are treated with antifungals irrespective the (1,3)-β-D-glucan results.

Sponsors & Collaborators

• Center for Clinical Studies, University Hospital Jena, Germany

  collaborator UNKNOWN

• Dept. of Microbiology, University Hospital Erlangen, Germany

  collaborator UNKNOWN

• Institute of Medical Statistics, Computer Sciences and Documentation, University Hospital Jena, Germany

  collaborator UNKNOWN

• Federal Ministry of Education and Research, Berlin, Germany

  collaborator UNKNOWN

• Associates of Cape Cod, Inc., East Falmouth, MA, USA

  collaborator UNKNOWN

• Center for Sepsis Control and Care, Germany

  lead OTHER

Principal Investigators

• Frank Bloos, MD, Ph.D. · Jena University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-12

Primary Completion

2019-08-22

Completion

2019-09-17

Countries

• Germany

Study Locations