Untargeted antifungal therapy in adult patients with complicated intra-abdominal infection: protocol for a systematic review with meta-analysis

INTRODUCTION: Intra-abdominal infections are the second most frequent cause of sepsis. In a recent cohort, fungal specimens were found in 51.9% of all patients with sepsis and peritonitis. Current systematic reviews comparing untargeted antifungal treatment with placebo or no treatment in patients who are critically ill have provided conflicting results, and clinical equipoise exists. Accordingly, we aim to assess patient-important benefits and harms of untargeted antifungal therapy versus placebo or no treatment in adult patients with complicated intra-abdominal infection. METHODS AND ANALYSIS: We will conduct a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials assessing any untargeted antifungal therapy compared with placebo or no treatment in adult patients with complicated intra-abdominal infections. The primary outcome is all-cause mortality, and secondary outcomes include adverse events, duration of mechanical ventilation and inotropic support, need for renal replacement therapy, emergence of antibiotic resistance and intensive care unit and hospital length-of-stay. Conventional meta-analysis, including sensitivity and subgroup analyses, and assessment of the risk of systematic (bias) and random errors will be conducted. The review will be prepared according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, the Cochrane methodology and the Grading of Recommendations, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Ethical approval is not required as this systematic review only includes previously published data. We aim to publish the review in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: International Prospective Register of Systematic Reviews registration number: CRD42016053508.