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Changes in the Association between Diagnostic Testing Method, PCR Ribotype, and Clinical Outcomes from Clostridioides difficile Infection: One Institution's Experience.

BACKGROUND
In patients with Clostridioides difficile infection (CDI), the relationship between clinical, microbial, and temporal/epidemiological trends relate and disease severity and adverse outcomes is incompletely understood. Here, in a follow-up to our study conducted in 2010-2013, we evaluate stool toxin levels and C. difficile PCR ribotypes. We hypothesized that elevated stool toxins and infection with ribotype 027 associate with severe disease and adverse outcomes.


METHODS
In a cohort of 565 subjects at the University of Michigan with CDI diagnosed by positive testing for toxins A/B by EIA or PCR for the tcdB gene, we quantified stool toxin levels via a modified cell cytotoxicity assay, isolated C. difficile by anaerobic culture, and performed PCR ribotyping. Severe CDI was defined by IDSA criteria, and primary outcomes were all-cause 30-day mortality and a composite of colectomy, ICU admission, and/or death attributable to CDI within 30 days. Analyses included bivariable tests and adjusted logistic regression.


RESULTS
199 samples were diagnosed by EIA and 447 were diagnosed by PCR. Toxin positivity associated with IDSA severity, but not primary outcomes. In 2016, compared to 2010-2013, ribotype 106 newly emerged, accounting for 10.6% of strains, ribotype 027 fell from 16.5% to 9.3%, and ribotype 014-027 remained stable at 18.9%. Ribotype 014-020 associated with IDSA severity and 30-day mortality (P=.001).


CONCLUSION
Toxin positivity by EIA and CCA associated with IDSA severity, but not with subsequent adverse outcomes. The molecular epidemiology of C. difficile has shifted, and this may have implications for the optimal diagnostic strategy for and clinical severity of CDI.