Trial document



drksid header

  DRKS00010285

Trial Description

start of 1:1-Block title

Title

(1,3)-β-D-glucan based diagnosis of invasive candida infection versus culture based diagnosis in patients with severe sepsis or septic shock and a high risk for invasive candida infection.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CandiSep

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Critically ill patients with severe infections are in need of a broad antibiotic therapy. However, severe fungal infections are rather rare and should only be treaded if proven. Proof of fungal infections takes several day - time which is lost for adequate treatment. An untreated fungal infection is a high risk for critically ill patients. (1,3)-β-D-glucan (BDG) is part of many fungi and appears fast in the blood of infected patients. Several studies already used measurement of BDG to diagnose severe fungal infections. However, it is controversial whether this test works on an intensive care unit. This study investigates whether BDG measurements in critically ill patients facilitates an early antifungal therapy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

(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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010285
  •   2016/08/22
  •   2016/04/06
  •   yes
  •   Approved
  •   4754-04/16, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1181-8724 
  •   NCT02734550  (Clinicaltrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   A41 -  Other sepsis
  •   Severe sepsis, septic shock
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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.
  •   (1,3)-β-D-glucan guided therapy: In addition to standard care, 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 bod fluids positive for fungi are treated with antifungals irrespective the (1,3)-β-D-glucan results.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

28-day mortality

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

28-day antifungal free survival, candida colonization, time to antifungal therapy, duration of organ support, 14 days mean total SOFA score, ICU und hospital length of stay, ICU ans hospital survival, adverse events, diagnostic accuracy of (1,3)-β-D-glucan in comparison to candida PCR and other experimental diagnostics, paracoeconomic analyses

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/09/13
  •   312
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Severe sepsis or septic shock
Increased risk for invasive candida infection (at least one of the following):
> 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
Onset of sepsis no longer than 24 hours
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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Friedrich-Schiller-Universität JenaMedizinische Fakultät
    • Bachstr. 18
    • 07743  Jena
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Jena University Hospital Center for Sepsis Control & Care
    • Mr.  PD Dr. med.  Frank  Bloos 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Jena University Hospital Center for Sepsis Control & Care
    • Mr.  PD Dr. med.  Frank  Bloos 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Jena University HospitalCenter for Sepsis Control & Care (CSCC)
    • Mr.  Daniel  Thomas-Rüddel 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Associates of Cape Cod, Inc.
    • Mr.  Dr.  Malcolm  Finkelman 
    • 124 Bernard St. Jean Drive
    • 02536  East Falmouth
    • United States
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2019/09/17
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.