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

Center for Sepsis Control and Care, Germany

Status: Completed

Conditions: Severe Sepsis; Septic Shock

Treatments: Other: Standard of care; Other: (1,3)-β-D-glucan guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02734550

ZKSJ0087

U1111-1181-8724 (Registry Identifier)

01EO1502 (Other Grant/Funding Number)

DRKS00010285 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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342 participants in 2 patient groups

Control

Active Comparator group

Description:

Diagnosis of invasive candida infection according to standard of care.

Treatment:

Other: Standard of care

(1,3)-β-D-glucan guidance

Experimental group

Description:

Treatment according to BDG-result

Treatment:

Other: (1,3)-β-D-glucan guided therapy

Other: Standard of care