Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734550
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : August 21, 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Frank Bloos, MD, Ph.D. +49-3641-9323101 frank.bloos@med.uni-jena.de
Contact: Daniel Thomas-Rüddel, MD +49-3641-9323267 daniel.thomas@med.uni-jena.de

Locations
Layout table for location information
Germany
Hospital Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Ulrich Jaschinksi, MD       ulrich.jaschinski@klinikum-augsburg.de   
Contact: Ilse Kreuzer       ilse.kreuzer@klinikum-augsburg.de   
HELIOS Klinikum Bad Saarow Active, not recruiting
Bad Saarow, Germany
Hospital Bielefeld Withdrawn
Bielefeld, Germany, 33617
University Hospital Bonn Recruiting
Bonn, Germany
Contact: Christian Putensen, MD       christian.putensen@ukbonn.de   
Hospital Emden Recruiting
Emden, Germany, 26721
Contact: K. Kogelmann, MD       k.kogelmann@klinikum-emden.de   
Helios Hospital Erfurt Withdrawn
Erfurt, Germany, 99089
University Hospital Erlangen Terminated
Erlangen, Germany
University Hospital Frankfurt Recruiting
Frankfurt, Germany, 60590
Contact: Patrick Meybohm, MD       patrick.meybohm@kgu.de   
University Hospital Göttingen Recruiting
Gottingen, Germany, 37099
Contact: Onnen Mörer, M.D.       omoerer@med.uni-goettingen.de   
University Hospital Greifswald Recruiting
Greifswald, Germany, 17475
Contact: S.-O. Kuhn, MD       kuhn@uni-greifswald.de   
University Hospital Halle Active, not recruiting
Halle, Germany
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Stefan Kluge, MD       skluge@uke.de   
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Markus Weigand, MD       markus.weigand@med.uni-heidelberg.de   
Jena University Hospital Recruiting
Jena, Germany, 07740
Contact: Frank Bloos, MD, Ph.D.       frank.bloos@med.uni-jena.de   
Contact: Daniel Thomas-Rüddel, MD       daniel.thomas@med.uni-jena.de   
University Hospital Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Norbert Weiler, MD       weiler@anaesthesie.uni-kiel.de   
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Philipp Simon, MD       Philipp.Simon@medizin.uni-leipzig.de   
University Hospital Münster Recruiting
Münster, Germany
Contact: Alexander Zarbock, MD       zarbock@uni-muenster.de   
Hospital Oldenburg Recruiting
Oldenburg, Germany, 26133
Contact: Andreas Weyland, MD       Weyland.Andreas@klinikum-oldenburg.de   
Contact: Anja Diers       diers.anja@klinikum-oldenburg.de   
Diakonie Klinikum Active, not recruiting
Siegen, Germany
Helios-Klinikum Wuppertal Withdrawn
Wuppertal, Germany
University Hospital Würzburg Active, not recruiting
Würzburg, Germany
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
Layout table for investigator information
Principal Investigator: Frank Bloos, MD, Ph.D. Jena University Hospital

Publications:
Layout table for additonal information
Responsible Party: Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier: NCT02734550     History of Changes
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: August 21, 2019
Last Verified: August 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:
Layout table for MeSH terms
Infection
Sepsis
Toxemia
Shock, Septic
Candidiasis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Mycoses
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors