Status:
COMPLETED
(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis
Lead Sponsor:
Center for Sepsis Control and Care, Germany
Collaborating Sponsors:
Center for Clinical Studies, University Hospital Jena, Germany
Dept. of Microbiology, University Hospital Erlangen, Germany
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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 diagn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT02734550
Start Date
September 12 2016
End Date
September 17 2019
Last Update
August 19 2022
Active Locations (18)
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1
Hospital Augsburg
Augsburg, Germany, 86156
2
HELIOS Klinikum Bad Saarow
Bad Saarow, Germany
3
University Hospital Bonn
Bonn, Germany
4
Hospital Emden
Emden, Germany, 26721