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

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ClinicalTrials.gov Identifier: NCT02734550
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Center for Clinical Studies, University Hospital Jena, Germany
Dept. of Microbiology, University Hospital Erlangen, Germany
Institute of Medical Statistics, Computer Sciences and Documentation, University Hospital Jena, Germany
Federal Ministry of Education and Research, Berlin, Germany
Associates of Cape Cod, Inc., East Falmouth, MA, USA
Information provided by (Responsible Party):
Center for Sepsis Control and Care, Germany

Tracking Information
First Submitted Date  ICMJE April 6, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE September 12, 2016
Actual Primary Completion Date August 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
28 day mortality [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • 28 day antifungal-free survival [ Time Frame: 28 days ]
  • Candida Colonization [ Time Frame: 14 days ]
    Candida colonization assessed by Candida Colonization Index
  • Time to antifungal therapy [ Time Frame: 14 days ]
  • Duration of organ support [ Time Frame: 14 days ]
  • Mean total SOFA score [ Time Frame: 14 days ]
    Measure of organ dysfunction
  • ICU and hospital length of stay [ Time Frame: Hospital length of stay ]
  • ICU and hospital mortality [ Time Frame: Hospital length of stay ]
  • Adverse events [ Time Frame: 14 days ]
  • Diagnostic performance of (1,3)-β-D-glucan in comparison to PCR and other experimental diagnostics [ Time Frame: 2 days ]
  • Pharmacoeconomics [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis
Official Title  ICMJE (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection Versus Culture Based Diagnosis in Patients With Severe Sepsis or Septic Shock
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
investigator-initiated prospective, multicenter, randomized, open, and parallel group study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Severe Sepsis
  • Septic Shock
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Control
    Diagnosis of invasive candida infection according to standard of care.
    Intervention: Other: Standard of care
  • Experimental: (1,3)-β-D-glucan guidance
    Treatment according to BDG-result
    Interventions:
    • Other: Standard of care
    • Other: (1,3)-β-D-glucan guided therapy
Publications * Bloos F, Held J, Schlattmann P, Brillinger N, Kurzai O, Cornely OA, Thomas-Rüddel D. (1,3)-β-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with sepsis and with an increased risk of invasive Candida infection (CandiSep): study protocol for a randomized controlled trial. Trials. 2018 Sep 4;19(1):472. doi: 10.1186/s13063-018-2868-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2019)
342
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
334
Actual Study Completion Date  ICMJE September 17, 2019
Actual Primary Completion Date August 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02734550
Other Study ID Numbers  ICMJE ZKSJ0087
01EO1502 ( Other Grant/Funding Number: Federal Ministry of Education and Research of Germany )
U1111-1181-8724 ( Registry Identifier: Universal Trial Number )
DRKS00010285 ( Registry Identifier: German Clinical Trial Register )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Center for Sepsis Control and Care, Germany
Study Sponsor  ICMJE Center for Sepsis Control and Care, Germany
Collaborators  ICMJE
  • Center for Clinical Studies, University Hospital Jena, Germany
  • Dept. of Microbiology, University Hospital Erlangen, Germany
  • Institute of Medical Statistics, Computer Sciences and Documentation, University Hospital Jena, Germany
  • Federal Ministry of Education and Research, Berlin, Germany
  • Associates of Cape Cod, Inc., East Falmouth, MA, USA
Investigators  ICMJE
Principal Investigator: Frank Bloos, MD, Ph.D. Jena University Hospital
PRS Account Center for Sepsis Control and Care, Germany
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP