(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis (NCT02734550) | Clinical Trial Compass
CompletedNot Applicable
(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis
Germany342 participantsStarted 2016-09-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
28 day mortality
Timeframe: 28 days
Trial details
NCT IDNCT02734550
SponsorCenter for Sepsis Control and Care, Germany