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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

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Other: Standard of care Other: (1,3)-β-D-glucan guided therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
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
Official Title: (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection Versus Culture Based Diagnosis in Patients With Severe Sepsis or Septic Shock
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Diagnosis of invasive candida infection according to standard of care.
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.

Experimental: (1,3)-β-D-glucan guidance
Treatment according to BDG-result
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.




Primary Outcome Measures :
  1. 28 day mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734550


Locations
Show Show 18 study locations
Sponsors and Collaborators
Center for Sepsis Control and Care, Germany
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
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Principal Investigator: Frank Bloos, MD, Ph.D. Jena University Hospital
Publications:
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Responsible Party: Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier: NCT02734550    
Other Study ID Numbers: 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 )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Center for Sepsis Control and Care, Germany:
Sepsis
Invasive Candida Infection
Biomarker
(1,3)-β-D-glucan
Antifungal therapy
Intensive care medicine
Critically ill
Additional relevant MeSH terms:
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Infection
Sepsis
Toxemia
Shock, Septic
Candidiasis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Mycoses