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

Not Applicable

Completed

• Conditions: Septic Shock; Severe Sepsis
• Interventions: Other: Standard of care; Other: (1,3)-β-D-glucan guided therapy

• Registration Number: NCT02734550
• Lead Sponsor: Center for Sepsis Control and Care, Germany

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Study Start: 2016-09-12
• Primary Completion: 2019-08-22
• Study Completion: 2019-09-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Severe sepsis or septic shock

• Onset of sepsis no longer than 24 hours

• Increased risk of invasive candida infection with at least one of the following criteria:

  • total parenteral nutrition ≥48 hours
  • abdominal surgery within the last 7 days
  • antimicrobial therapy for at least 48 hours within the last 7 days
  • Acute or chronic renal failure with renal replacement therapy

• Age ≥18 years

• Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.

Exclusion Criteria

• Pregnant or lactating women
• Ongoing invasive candida infection
• systemic antifungal therapy
• liver cirrhosis Child C
• cardiopulmonary bypass within the last 4 weeks
• treatment with immunoglobulins within the last 14 days
• immunosuppression (solid organ transplantation, AISA, leukopenia)
• participation in another intervention study
• no commitment to full therapy (i.e. DNR order)
• Infauste Prognose aufgrund von Nebenerkrankungen
• kin to or colleague of study personnel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(1,3)-β-D-glucan guidance	Standard of care	Treatment according to BDG-result
Control	Standard of care	Diagnosis of invasive candida infection according to standard of care.
(1,3)-β-D-glucan guidance	(1,3)-β-D-glucan guided therapy	Treatment according to BDG-result

Primary Outcome Measures

Name	Time	Method
28 day mortality	28 days

Secondary Outcome Measures

Name	Time	Method
28 day antifungal-free survival	28 days
Candida Colonization	14 days	Candida colonization assessed by Candida Colonization Index
Duration of organ support	14 days
ICU and hospital mortality	Hospital length of stay
Diagnostic performance of (1,3)-β-D-glucan in comparison to PCR and other experimental diagnostics	2 days
Time to antifungal therapy	14 days
Mean total SOFA score	14 days	Measure of organ dysfunction
ICU and hospital length of stay	Hospital length of stay
Pharmacoeconomics	14 days
Adverse events	14 days

Trial Locations

Locations (18)

Hospital Augsburg; 🇩🇪 Augsburg, Germany

HELIOS Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

University Hospital Bonn; 🇩🇪 Bonn, Germany

Hospital Emden; 🇩🇪 Emden, Germany

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

University Hospital Frankfurt; 🇩🇪 Frankfurt, Germany

University Hospital Göttingen; 🇩🇪 Gottingen, Germany

University Hospital Greifswald; 🇩🇪 Greifswald, Germany

University Hospital Halle; 🇩🇪 Halle, Germany

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

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