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NCT Number: NCT02734550

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

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.

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Key information

Conditions

Severe Sepsis Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Augsburg, Augsburg, Germany

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About this study

(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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

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.

(1,3)-β-D-glucan guided therapy

Other

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.

Primary outcomes

  1. 28 day mortality

    Time frame: 28 days

Secondary outcomes

  1. 28 day antifungal-free survival

    Time frame: 28 days

  2. Candida Colonization

    Time frame: 14 days

    Candida colonization assessed by Candida Colonization Index

  3. Time to antifungal therapy

    Time frame: 14 days

  4. Duration of organ support

    Time frame: 14 days

  5. Mean total SOFA score

    Time frame: 14 days

    Measure of organ dysfunction

  6. ICU and hospital length of stay

    Time frame: Hospital length of stay

  7. ICU and hospital mortality

    Time frame: Hospital length of stay

  8. Adverse events

    Time frame: 14 days

  9. Diagnostic performance of (1,3)-β-D-glucan in comparison to PCR and other experimental diagnostics

    Time frame: 2 days

  10. Pharmacoeconomics

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Center for Sepsis Control and Care, Germany

Other

Collaborators

  • Associates of Cape Cod, Inc., East Falmouth, MA, USA
  • Dept. of Microbiology, University Hospital Erlangen, Germany
  • Federal Ministry of Education and Research, Berlin, Germany
  • Jena University Hospital

Registry information

Official study title

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

Acronym: CandiSep

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2016
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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