(1,3)-ß-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.

Not Applicable

• Conditions: Severe sepsis, septic shock; A41; Other sepsis

• Registration Number: DRKS00010285
• Lead Sponsor: Friedrich-Schiller-Universität JenaMedizinische Fakultät

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-22
• Study Completion: 2019-09-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 342

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.

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality

Secondary Outcome Measures

Name	Time	Method
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)-ß-D-glucan in comparison to candida PCR and other experimental diagnostics, paracoeconomic analyses<br>