(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
2018
The time to diagnosis of invasive
Candida infection(ICI) is often too long to initiate timely
antifungaltherapy in patients with sepsis. Elevated serum (1,3)-β-D-glucan (BDG) concentrations have a high diagnostic sensitivity for detecting ICI. However, the clinical significance of elevated BDG concentrations is unclear in critically ill patients. The goal of this study is to investigate whether measurement of BDG in patients with sepsis and a high risk for ICI can be used to decrease the time to empiric
antifungaltherapy and thus, increase survival. This prospective multicenter open randomized controlled trial is being conducted in 19 German intensive care units. All adult patients with severe sepsis or septic shock and an increased risk for ICI are eligible for enrolment. Risk factors are total parenteral nutrition, previous abdominal surgery, previous antimicrobial therapy, and renal replacement therapy. Patients with proven ICI or those already treated with systemic
antifungalsubstances are excluded. Patients are allocated to a BDG or standard care group. The standard care group receives targeted
antifungaltherapy as necessary. In the BDG group, BDG serum samples are taken after randomization and 24 h later.
Antifungaltherapy is initiated if BDG is ≥80 pg/ml in at least one sample. We plan to enroll 312 patients. The primary outcome is 28-day mortality. Other outcomes include
antifungal-free survival within 28 days after enrolment, time to
antifungaltherapy, and the diagnostic performance of BDG compared to other laboratory tests for early ICI diagnosis. The statistical analysis will be performed according to the intent-to-treat principle. Because of the high risk of death, American guidelines recommend empiric
antifungaltherapy in sepsis patients with a high risk of ICI despite the limited evidence for such a recommendation. In contrast, empiric
antifungaltherapy is not recommended by European guidelines. BDG may offer a way out of this dilemma since BDG potentially identifies patients in need of early
antifungals. However, the evidence for such an approach is inconclusive. This clinical study will generate solid evidence for health-care providers and authors of guidelines for the use of BDG in critically ill patients. Clinicaltrials.gov, NCT02734550 . Registered 12 April 2016.
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