Trial document

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DRKS-ID: DRKS00010285

Trial Description

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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.

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Trial Acronym

CandiSep

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URL of the Trial

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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.

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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.

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

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00010285
Date of Registration in DRKS: 2016/08/22
Date of Registration in Partner Registry or other Primary Registry: 2016/04/06
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 4754-04/16, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät

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Secondary IDs

Universal Trial Number (UTN): U1111-1181-8724
Primary Registry-ID: NCT02734550 (Clinicaltrials.gov)

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Health Condition or Problem studied

ICD10: A41 - Other sepsis
Free text: Severe sepsis, septic shock

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Interventions/Observational Groups

Arm 1: 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.
Arm 2: (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.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control (effective treament of control group)
Purpose: Diagnostic
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

28-day mortality

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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

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Medical Center Klinikum Augsburg, Augsburg
Medical Center Klinikum Emden, Emden
University Medical Center Universitätsklinikum Göttingen, Göttingen
University Medical Center Universitätsmedizin Greifswald, Greifswald
University Medical Center Universitätsklinikum Frankfurt, Frankfurt a.M.
University Medical Center Universitätsklinikum Hamburg-Eppendorf, Hamburg
University Medical Center Universitätsklinikum Heidelberg, Heidelberg
University Medical Center Universitätsklinikum Jena, Jena
University Medical Center Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel
University Medical Center Universitätsklinikum Leipzig, Leipzig
University Medical Center Klinikum Oldenburg, Oldenburg
University Medical Center Bonn
Medical Center HELIOS Klinikum Bad Saarow, Bad Saarow
University Medical Center Universitätsklinikum Erlangen, Erlangen
Medical Center Diakonie Klinikum, Siegen
University Medical Center Universitätsklinikum Halle(Saale), Halle Saale
University Medical Center Münster, Münster
University Medical Center Würzburg, Würzburg

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2016/09/13
Target Sample Size: 312
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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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.

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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

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Addresses

Primary Sponsor
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- Friedrich-Schiller-Universität JenaMedizinische Fakultät
- Bachstr. 18
- 07743 Jena
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uni-jena.de/Medizinische_Fakultaet.html
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Contact for Scientific Queries
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- Jena University Hospital Center for Sepsis Control & Care
- Mr. PD Dr. med. Frank Bloos
- Am Klinikum 1
- 07747 Jena
- Germany
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- Telephone: +49-3641-9323283
- Fax: +49-3641-9323102
- E-mail: frank.bloos at med.uni-jena.de
- URL: http://www.cscc.uniklinikum-jena.de
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Contact for Public Queries
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- Jena University Hospital Center for Sepsis Control & Care
- Mr. PD Dr. med. Frank Bloos
- Am Klinikum 1
- 07747 Jena
- Germany
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- Telephone: +49-3641-9323283
- Fax: +49-3641-9323102
- E-mail: frank.bloos at med.uni-jena.de
- URL: [---]*
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Contact for Public Queries
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- Jena University HospitalCenter for Sepsis Control & Care (CSCC)
- Mr. Daniel Thomas-Rüddel
- Am Klinikum 1
- 07747 Jena
- Germany
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- Telephone: +49-3641-9323267
- Fax: +49-3641-9323102
- E-mail: daniel.thomas at med.uni-jena.de
- URL: http://www.cscc.uniklinikum-jena.de
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Friedrichstraße 130 B
- 10117 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.bmbf.de
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Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Associates of Cape Cod, Inc.
- Mr. Dr. Malcolm Finkelman
- 124 Bernard St. Jean Drive
- 02536 East Falmouth
- United States
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- Telephone: [---]*
- Fax: [---]*
- E-mail: mfinkelman at acciusa.com
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): 2019/09/17
Number of Participants in Germany after Recruiting complete: 342
Total Number of Participants (all Sites worldwide) after Recruiting complete: 342

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Trial Publications, Results and other Documents

trial protocol (mandatory for transfer to Studybox): 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. PMID: 30180873; PMCID: PMC6124015.

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