Pancreatic Stone Protein as an Early Prognostic Biomarker of Outcome in Clostridioides Difficile Infection.

Abstract

Background: Clostridioides difficile infection (CDI) remains a major healthcare-associated infection, leading to severe complications. Early identification of patients at high risk for unfavorable outcomes remains challenging. Pancreatic stone protein (PSP) has emerged as a promising biomarker in sepsis; however, its role in CDI has not been investigated.

Materials and methods: We conducted a prospective multicenter study of adult patients with CDI from 13 study sites in Greece. PSP was measured within 24 hours of CDI onset. The primary outcome was the association between PSP and unfavorable outcome, defined as at least one of the following: organ failure, severe disease progression, relapse, or death. Receiver operating characteristic curve was performed to assess diagnostic performance, and multivariate logistic regression to evaluate independent predictors of adverse outcome.

Results: One hundred forty-seven patients were enrolled, and unfavorable outcomes occurred in 52. PSP levels were significantly higher in these patients. PSP showed an area under the curve of 0.648 [95% confidence interval (CI) 0.550-0.746, P = 0.003] for predicting adverse outcome and an optimal cutoff of 300 ng/mL, which increased the risk significantly (odds ratio 3.73, 95% CI 1.822-7.638, P < 0.001). C-reactive protein (CRP) was also associated with adverse outcome (area under the curve 0.619, 95% CI 0.512-0.726, P : 0.03), with an optimal cutoff ≥90 mg/L. Combined elevation of PSP and CRP conferred stronger prognostic value (odds ratio 7.04, 95% CI 2.78-17.85, P < 0.001). In multivariate analysis, PSP ≥300 ng/mL ( P : 0.006) and CRP ≥90 mg/L ( P : 0.04) remained independently associated with unfavorable outcome.

Conclusions: This is the first study evaluating PSP in CDI. PSP, especially combined with CRP, may serve as complementary biomarkers for early risk stratification.